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From: TSS ()
Greetings CJDVoice et al, dave ask if i might have a few questions to submit, which i did, and i thought i might now reveal the answers. ----- Original Message ----- a suggestion or two ; WHAT EVER HAPPENED TO THE RESULTS OF THE ''CJD LOOK BACK STUDY'' ??? would it not seem more important now than ever ??? Due to the recent discovery of two cases of vCJD blood transfusion transmission in the U.K. the American Red Cross, at the October 14 FDA TSEAC meeting, announced an acceleration of their "Look Back" study implemented in 1995. In this study all blood and blood products donated to the American Red Cross by a person who subsequently died of CJD will be traced. This "Look Back" study is a very important one for all of our families of CJD patients, past and present. If your loved one was a blood donor or a blood recipient and you wish to participate please contact one of the names listed below. As the wife of a regular blood donor who died of CJD in 2000 I am relieved to know that this study is being given high priority by the ARC and the CDC. I know we all certainly hope that sCJD is not a vector, however, we won't know unless this research is conducted. The recipients of any whole blood or blood product donated by a person who subsequently died of CJD will NOT be notified unless medically appropriate notification and counseling is deemed necessary by the health care provider. Contact Information: Kerri Dorsey, MPH Shimian Zou, PhD HOW can the FDA or anyone claim that the USA blood program is safe (in terms of Transmissible Spongiform Encephalopathy's), if you consider the following ; From: Terry S. Singeltary Sr. To: FREAS@CBER.FDA.GOV Cc: william.freas@fda.hhs.gov ; rosanna.harvey@fda.hhs.gov Sent: Wednesday, November 29, 2006 1:24 PM Subject: TSE advisory committee for the meeting December 15, 2006 [TSS SUBMISSION] November 29, 2006 Greetings FDA, DHH, Dr. Freas, and Dr. Harvey et al, snip... THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted blood from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone. These are the facts as i have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species. ... Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518 snip... see full text 48 pages, 1st page starts on page 13. ...TSS Greetings again CJDVoice et al; ''Thanks again for your help today.'' snip...end http://www.fda.gov/ohrms/dockets/ac/cber09.html#CellularTissueGeneTherapies HOPEFULLY, it will not be the same old BSe at the FDA. Posted by Dave Cavenaugh 02-19-2009 COTT ACTION MAD COW ALERT FOR PEOPLE WITH HEMOPHILIA UK Finds Mad Cow Can Be Transmitted Through Blood Supply Washington, DC February 19, 2009 -- PRODUCT Source Plasma, Recall # B-0054-7 CODE Units: 03MMNC5465, 03MMNC6361, 03MMNC6801, 03MMNC7510, 03MMNC7891, 03MMNC8252, 03MMNC8801, 03MMNC9144, 03MMND1122, 03MMND1478, 03MMND1969, 03MMND2350, 03MMND2825, 03MMND3211, 03MMND3708, 03MMND4072, 03MMND4588, 03MMND4831, 03MMND5320, 03MMND5719, 03MMND6268, 03MMND6683, 03MMND7228, 03MMND7656, 03MMND8211, 03MMND8652, 03MMND9195, 03MMND9618, 03MMNE0628, 03MMNE0884, 03MMNE1597, 03MMNE1979, 03MMNE2644, 03MMNE3064, 03MMNE3707, 03MMNE4122, 03MMNE4750, 03MMNE5080, 03MMNE5876, 03MMNE6218, 03MMNE7189, 03MMNE7587, 03MMNE8027, 03MMNE8645, 03MMNE9029, 03MMNE9641, 03MMNE9979, 03MMNF0491, 03MMNF0685, 03MMNF0937, 03MMNF1260, 04MMNA0351, 04MMNA0707, 04MMNA1241, 04MMNA1650, 04MMNA2291, 04MMNA2646, 04MMNA3340, 04MMNA3719, 04MMNA4312, 04MMNA4683, 04MMNA5298, 04MMNA5750, 04MMNA6407, 04MMNA6816, 04MMNA7482, 04MMNA7915, 04MMNA8632, 04MMNA9076, 04MMNA9723, 04MMNB0063, 04MMNB0696, 04MMNB1100, 04MMNB1845, 04MMNB2285, 04MMNB3035, 04MMNB3485, 04MMNB4213, 04MMNB4672, 04MMNB5841, 04MMNB6652, 04MMNB7162, 04MMNB7930, 04MMNB8453, 04MMNB9239, 04MMNB9747, 04MMNC0456, 04MMNC0931, 04MMNC1578 RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Mankato, MN, by facsimile on June 4, 2004. Firm initiated recall is complete. REASON Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 89 units DISTRIBUTION CA and Austria END OF ENFORCEMENT REPORT FOR October 25, 2006 ### http://www.fda.gov/bbs/topics/enforce/2006/ENF00975.html RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ______________________________ PRODUCT Source Plasma, Recall # B-1708-6 CODE Units: MI180733, MI180927, MI181625, MI181780, MI182337, MI182519, MI183140, MI183311, MI183955, MI185006, MI185278, MI185822, MI186081, MI186855, MI187183, MI187903, MI188273, MI188695, MI189257, MI189553, MI190136, MI190473, MI191073, MI191395, MI191972, MI192303, MI193473, MI194343, 04MINA0377, 04MINA0801, 05MINA7147, 05MINA7451, 05MINA8094, 05MINA8504, 05MINA9548, 05MINA9883, 05MINB0489, 05MINB0875, 05MINB1469, 05MINB1874, 05MINB3116, 05MINB7192, 05MINB7529, 05MINB8246, 05MINB8612, 05MINB9236, 05MINB9366, 05MINB9475, 05MINB9641, 05MINC0031, 05MINC0237, 05MINC0336, 05MINC0894, 05MINC0964, 05MINC1138, 05MINC1619, 05MINC1750, 05MINC1907, 05MINC1977, 05MINC2375, 05MINC2774, 05MINC3113, 05MINC3484, 05MINC4277, 05MINC4623, 05MINC5623, 05MINC5914, 05MINC7545, 05MINC7870, 05MINC8355, 05MINC8689, 05MINC9437, 05MINC9775, 05MIND0067, 05MIND0393, 05MIND0892, 05MIND0951, 05MIND1836, 05MIND2183 and 05MIND2962 RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Muncie, IN, by facsimile on November 22, 2005. Firm initiated recall is complete. REASON Blood products, collected from unsuitable donors based on risk factors for Creutzfeldt-Jakob Disease (CJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 80 units DISTRIBUTION CA, NC, and MD ______________________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1714-6; b) Fresh Frozen Plasma, Recall # B-1715-6; c) Platelets, Recall # B-1716-6 CODE a), b), and c) Unit: 2443732 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by letters dated November 11, 2003 and December 18, 2003. Firm initiated recall is complete. REASON Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION TX and WI END OF ENFORCEMENT REPORT FOR SEPTEMBER 13, 2006 ### http://www.fda.gov/bbs/topics/enforce/2006/ENF00969.html END OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 2006 ### http://www.fda.gov/bbs/topics/enforce/2006/ENF00968.html PRODUCT a) Red Blood Cells, Recall # B-1587-6; b) Cryoprecipitated AHF, Recall # B-1588-6; c) Recovered Plasma, Recal # B-1589-6 CODE a), b) and c) Unit: 2016719 RECALLING FIRM/MANUFACTURER Walter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on March 13, 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION GA and Germany ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6; b) Fresh Frozen Plasma, Recall # B-1591-6 CODE a) and b) Unit: 2443595 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 30, 2004. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6; b) Fresh Frozen Plasma, Recall # B-1593-6 CODE a) and b) Unit: 2545596 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 14, 2004 and January 3, 2005. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX ______________________________ http://www.fda.gov/bbs/topics/enforce/2006/ENF00963.html ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1555-6; b) Fresh Frozen Plasma, Recall # B-1556-6 CODE a) and b) Unit 2454970 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax on July 23 and December 11. 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX ______________________________ PRODUCT a) Red Blood Cells, Recall # B-1494-6 b) Cryoprecipitated AHF, Recall # B-1495-6 CODE a) and b) Unit 5013100 RECALLING FIRM/MANUFACTURER Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by fax on May 17, 2005. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION GA ______________________________ PRODUCT Source Plasma, Recall # B-1450-6 CODE Unit numbers ST0824313 and ST0824764 RECALLING FIRM/MANUFACTURER Stillwater Plasma Center LLC, Stillwater, OK, by fax on November 21, 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor whose suitability pertaining to risk factors for Creutzfeldt-Jakob Disease (vCJD) was not adequately determined, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION UK ______________________________ PRODUCT Plasma Frozen, Recall # B-1422-6; Recovered Plasma, Recall # B-1423-6 CODE a) Unit 03E42218; b) Unit 03E38153 RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Atlanta, GA, by telephone, e-mail or letter on February 20 or 21, 2004. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION GA and Switzerland ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1374-6; b) Recovered Plasma, Recall # B-1375-6 CODE a) and b) unit 2453906 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax on October 31 and November 5, 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX and Austria ______________________________ PRODUCT Source Plasma. Recall # B-1295-6 CODE Units: NG0046551, NG0045950 RECALLING FIRM/MANUFACTURER DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002, Firm initiated recall is complete. REASON Blood products, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire appropriately, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION KY ______________________________ PRODUCT Source Plasma. Recall # B-1296-6 CODE Unit: NG 0044520 RECALLING FIRM/MANUFACTURER DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 12, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor who did not answer the questions on the new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION KY ______________________________ PRODUCT Source Plasma. Recall # B-1297-6 CODE Units: NG0042874, NG0043139, NG0043312, NG0043618, NG0043797, NG0044020, NG0044209, NG0044507, NG0044718, NG0044977, NG0045161, NG0045412, NG0045555 RECALLING FIRM/MANUFACTURER DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 13 units DISTRIBUTION KY ______________________________ PRODUCT Source Plasma, Recall # B-1298-6 CODE Units: NG 0046823, NG 0046671, NG 0045205, NG 0044635, NG 0043095, NG 0042525, NG 0042341 RECALLING FIRM/MANUFACTURER DCI Biologicals Nacogdoches LLC, Nacogdoches, TX, by telephone and fax on December 20, 2002. Firm initiated recall is complete. REASON Blood products, collected from a donor who answered questions on the variant Creutzfeldt-Jacob disease (vCJD) questionnaire inappropriately, were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units DISTRIBUTION KY ______________________________ PRODUCT Recovered Plasma, Recall # B-1299-6 CODE Unit: 4357117 RECALLING FIRM/MANUFACTURER Department of the Navy, Naval Medical Center, San Diego, CA, by fax and letter on September 25, 2003. Firm initiated recall is complete. REASON Blood product, collected from a donor considered to be at risk of exposure to Creutzfeldt-Jacob Disease (CJD), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION Germany END OF ENFORCEMENT REPORT FOR July 12, 2006 ### http://www.fda.gov/bbs/topics/enforce/2006/ENF00960.html FDA mad cow nvCJD 'only' blood recalls 1ST WEEK JULY PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1379-6; b) Platelets, Recall # B-1380-6; c) Fresh Frozen Plasma, Recall # 1381-6; d) Recovered Plasma, Recall # B-1382-6 CODE a) Unit numbers: 2343106, 2377779, and 2403533; b) and c) Unit numbers: 2377779; d) Unit numbers: 2343106 and 2403533 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 12, 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units DISTRIBUTION TX and Austria ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1467-6; b) Recovered Plasma, Recall # B-1468-6 CODE a) and b) Unit numbers: 2329380 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on May 8, 2003. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX and Switzerland ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1479-6; b) Cryoprecipitated AHF, Recall # B-1480-6; c) Recovered Plasma, Recall # B-1481-6 CODE a), b), and c) Unit numbers: 2383280 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on July 23 and 29, 2004. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION TX and Switzerland ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1482-6; b) Fresh Frozen Plasma, Recall # B-1483-6 CODE a) and b) Unit number: 2501452 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on October 5, 2004. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION TX and NY ______________________________ PRODUCT a) Red Blood Cells Leukocytes Reduced, Recall # B-1484-6; b) Plasma Cryoprecipitated Reduced, Recall # B-1485-6; c) Recovered Plasma, Recall # B-1486-6 CODE a) and c) Unit number: 2554077; b) Unit number: 2415708 RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 13, 2004. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units DISTRIBUTION TX and Austria _____________________________________ END OF ENFORCEMENT REPORT FOR July 5, 2006 ### http://www.fda.gov/bbs/topics/enforce/2006/ENF00959.html Greetings again Dr. Freas et al at FDA, PERSPECTIVE On the Question of Sporadic or Atypical Bovine Spongiform Encephalopathy and Creutzfeldt-Jakob Disease Paul Brown,* Lisa M. McShane,? Gianluigi Zanusso,? and Linda Detwiler§ THE USA is in a most unique situation, one of unknown circumstances with human and animal TSE. THE USA has the most documented TSE in different species to date, with substrains growing in those species (BSE/BASE in cattle and CWD in deer and elk, there is evidence here with different strains), and we know that sheep scrapie has over 20 strains of the typical scrapie with atypical scrapie documented and also BSE is very likely to have passed to sheep. all of which have been rendered and fed back to animals for human and animal consumption, a frightening scenario. WE do not know the outcome, and to play with human life around the globe with the very likely TSE tainted blood from the USA, in my opinion is like playing Russian roulette, of long duration, with potential long and enduring consequences, of which once done, cannot be undone. These are the facts as i have come to know through daily and extensive research of TSE over 9 years, since 12/14/97. I do not pretend to have all the answers, but i do know to continue to believe in the ukbsenvcjd only theory of transmission to humans of only this one strain from only this one TSE from only this one part of the globe, will only lead to further failures, and needless exposure to humans from all strains of TSE, and possibly many more needless deaths from TSE via a multitude of proven routes and sources via many studies with primates and rodents and other species. ... Terry S. Singeltary Sr. P.O. Box 42 Bacliff, Texas USA 77518 snip... see full text 48 pages, 1st page starts on page 13. ...TSS Saturday, December 08, 2007 Transfusion Transmission of Human Prion Diseases http://vcjdblood.blogspot.com/2006/12/vcjd-case-study-highlights-blood.html __,_._,___ ---------- https://lists.aegee.org/cjd-l.html ----------
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