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Carolinas Region Food and Drug Administration Adverse Determination Letter (ADL) VIEW \| DOWNLOAD FDA Inspection: none available at this time SNIPPET \| DOWNLOAD Recalls and Significant Blood Safety Violations 10/30/09: Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions answered). 10/30/09: Recalled 1 Fresh Frozen Plasma Productdue to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions answered). 10/30/09: Recalled 2 Red Blood Cells Leukocytes Reduced due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered). 10/30/09: Recalled 1 Plasma Frozen due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered). 10/30/09: Recalled 1 Red Blood Cells Leukocytes Reduced due to donor eligibility (failure to defer donor for travel to malarial risk area). 10/30/09: Recalled 2 Fresh Frozen Plasma Products due to collection (inadequate arm prep; sterility may have been compromised). 10/30/09: Recalled 4 Red Blood Cells Leukocytes Reduced Products due to collection (inadequate arm prep; sterility may have been compromised). 10/30/09: Recalled 1 Plasma Frozen Product due to collection (inadequate arm prep; sterility may have been compromised). 10/30/09: Recalled 1 Cryoprecipitated AHF Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered). 10/30/09: Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions answered). 10/30/09: Recalled 2 Red Blood Cells (Apheresis) Leukocytes Reduced Products due to quality control and distribution (failure to perform quality control testing on product). 10/30/09: Recalled 16 Red Blood Cells Leukocytes Reduced Products due to failure to control suspect blood component(s) (inappropriate release of blood components that should have been discarded for unacceptable shipping temperatures). 10/30/09: Recalled 237 Red Blood Cells Leukocytes Reduced Products due to testing (failure to perform syphilis testing properly). 10/30/09: Recalled 26 Red Blood Cells (Apheresis) Leukocytes Reduced Products due to testing (failure to perform syphilis testing properly). 10/30/09: Recalled 15 Platelets Pheresis Leukocytes Reduced Products due to testing (failure to perform syphilis testing properly). 10/30/09: Recalled 73 Fresh Frozen Plasma Products due to testing (failure to perform syphilis testing properly). 10/30/09: Recalled 27 Cryoprecipitated AHF Products due to testing (failure to perform syphilis testing properly). 10/30/09: Recalled 16 Plasma Cryoprecipitate Reduced Products due to testing (failure to perform syphilis testing properly). 10/30/09: Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions answered). 10/30/09: Recalled 1 Plasma Frozen Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered). 10/30/09: Recalled 2 Red Blood Cells Leukocytes Reduced Products due to donor eligibility (incorrect gender assigned; incorrect 10/30/09 : Blood Donation Record gender-spec\|f\|c questions were answered). 10/30/09: Recalled 1 Cryoprecipitated AHF Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered). 10/30/09: Recalled 1 Fresh Frozen Plasma Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered). 10/30/09: Recalled 2 Red Blood Cells Leukocytes Reduced Products due to donor eligibility (incorrect gender assigned; incorrect 10/30/09 : Blood Donation Record gender-spec\|f\|c questions were answered). Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect 10/30/09 : Blood Donation Record gender-spec\|f\|c questions answered). Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect 10/30/09 : Blood Donation Record gender-spec\|f\|c questions answered). Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect 10/30/09 : Blood Donation Record gender-spec\|f\|c questions answered). Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect 10/30/09 : Blood Donation Record gender-spec\|f\|c questions answered). 10/30/09: Recalled 2 Red Blood Cells (Apheresis) Products due to quality control and distribution (product did not meet specifica- dons) 10/30/09: Recalled 1 Red Blood Cells (Apheresis) Leukocytes Reduced Product due to component preparation (distribution of low volume unit). 10/30/09: Recalled 2 Red Blood Cells (Apheresis) Leukocytes Reduced Products due to donor eligibility (incorrect gender assigned, incorrect Blood Donation Record gender-spec\|f\|c questions were answered). 10/30/09: Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect 10/30/09 : Blood Donation Record gender-spec\|f\|c questions answered). Recalled 2 Red Blood Cells Leukocytes Reduced Products due to donor eligibility (incorrect gender assigned; incorrect 10/30/09 : Blood Donation Record gender-spec\|f\|c questions were answered). 10/30/09: Recalled 2 Fresh Frozen Plasma Products due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered). 10/30/09: Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for residence in a malarial risk area). 10/30/09: Recalled 2 Red Blood Cells Leukocytes Reduced Products due to donor eligibility (failure to defer donor for travel to a malarial risk area). 10/30/09: Recalled 1 Fresh Frozen Plasma Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered). 10/30/09: Recalled 1 Red Blood Cells Leukocytes Reduced Productdue to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions answered). 10/30/09: Recalled 1 Red Blood Cells Leukocytes Reduced Productdue to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions answered). 10/30/09: Recalled 1 Platelets Pheresis Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incor- rect Blood Donation Record gender-specific questions were answered). 10/30/09: Recalled 1 Red Blood Cells Leukocytes Reduced Productdue to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions answered). 10/30/09: Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a malarial risk area). 10/30/09: Recalled 1 Fresh Frozen Plasma Product due to failure to control suspect blood component(s) (inappropriate release after discovering clots in red blood cells). 2/6/08 : Recalled 1 Red Blood Cells Leukocytes Reduced Productdue to donor eligibility (incorrect identification used during deferral search for a donor previously deferred due to testing anti-HCV reactive). 2/6/08 : Recalled 1 Recovered Plasma Product due to donor eligibility (incorrect identification used during deferral search for a donor previously deferred due to testing anti-H CV reactive). 2/6/08 : Recalled 4 Red Blood Cells Leukocytes Reduced Products due to failure to control suspect blood component(s) ( inap- propriate release of blood components that should have been discarded). 2/6/08 : Recalled 2 Platelets Pheresis Leukocytes Reduced Products due to donor eligibility (Blood Donation Record questions unanswered). 2/6/08 : Recalled 2 Red Blood Cells Pheresis Leukocytes Reduced Products due to donor eligibility (Blood Donation Record questions related to current medication being take was unanswered). 2/6/08 : Recalled 1 Red Blood Cells Leukocytes Reduced Product due to failure to control suspect blood component(s) (release of blood components from a donor that was in a permanent deferral category). 2/6/08 : Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (unauthorized changes made to Blood Donation Record questions). 2/6/08 : Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (Blood Donation Record gender related questions were unanswered). 2/6/08 : Recalled 1 Fresh Frozen Plasma Product due to donor eligibility (Blood Donation Record gender related questions were unanswered). 2/6/08 : Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel in a malarial risk area). There are no FDA Inspection Report previews currently available for this region.

There are no FDA Inspection Report previews currently available for this region.