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Recalls and Significant Blood Safety Violations

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to failure to control suspect blood component(s) (inappropriate release of blood components that should have been discarded because donor was taking Coumadin).

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 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 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender specific questions were answered).

10/30/09:
Recalled 112 Red Blood Cells Leukocytes Reduced Products due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09:
Recalled 42 Platelets Pheresis Leukocytes Reduced Products due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09:
Recalled 24 Fresh Frozen Plasma Products due to collection (inadequate arm prep; sterility may have been compromised).

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 were answered).

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Irradiated 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 failure to control suspect blood component(s) (failure to quarantine component after discovery that donor had traveled 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 2 Red Blood Cells Leukocytes Reduced Products due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered).

10/30/09:
Recalled 2 Platelets Leukocytes Reduced Products 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).

2/6/08:
Recalled 37 Platelets Pheresis Leukocytes Reduced due to quality control and distribution (components collected using instruments whose quality control testing was not met for two months).

2/6/08:
Recalled 12 Platelets Pheresis Leukoctyes Reduced Irradiated due to quality control and distribution (components collected using instruments whose quality control testing was not met for two months).

2/6/08:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to failure to control suspect blood component(s) (failure to quarantine components after receiving information about post donation illness).

2/6/08:
Recalled 1 Fresh Frozen Plasma Product due to failure to control suspect blood component(s) (failure to quarantine components after receiving information about post donation illness).

2/6/08:
Recalled 1 Platelets Leukocytes Reduced Product due to failure to control suspect component(s) (failure to quarantine component from an overweight unit).

2/6/08:
Recalled 1 Platelets Leukocytes Reduced Product due to failure to control suspect component(s) (failure to quarantine component from an overweight unit).

The following excerpt is from page 1 of this 3-page FDA Inspection Report:

The review of 110 Donor Reaction and Injury Record (DRIR) forms (56 completed by the [REDACTED TEXT] and 54 completed by the [REDACTED TEXT] during the current inspection that were completed after the last inspection in 2009 revealed that 49 of the 110 Donor Reaction and Injury Record forms were not completed and/or documented as required by the instructions in Doc No. 15.4.frm015 Version 1.2 in effect during the time frame reviewed. The 110 Donor Reaction and Injury Record forms reviewed included Donor Reaction and Injury Record forms initiated by the TVR and completed by [REDACTED TEXT] when the reaction or injury occurred at the donation site and those initiated and completed by the [REDACTED TEXT] from donor call backs. The majority of the 49 of the Donor Reaction and Injury Record forms that were not completed and/or documented as required by the instructions in Doc No 15.4.frm015 Version 1.2 in effect during the time frame reviewed had multiple errors. The following types and number of documentation errors and the party responsible (TVR,[REDACTED TEXT] and [REDACTED TEXT] were noted during the review of the 49 Donor Reaction and Injury Record forms that were not completed and/or documented as required by the instructions in Doc No 15.4.frm015 Version 1.2 in effect during the time frame reviewed

Download the pdf file to read the complete inspection report.