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Recalls and Significant Blood Safety Violations

10/30/09:
Recalled 166 Platelets Pheresis Leukocytes Reduced Products due to quality control and distribution (inappropriate release of platelet components with unacceptable quality control)

10/30/09:
Recalled 16 Platelets Pheresis Leukocytes Reduced Irradiated Products due to quality control and distribution (inappropriate release of platelet components with unacceptable quality control)

10/30/09:
Recalled 4 Platelets Pheresis Leukocytes Reduced Washed Products due to quality control and distribution (inappropriate release of platelet components with unacceptable quality control).

10/30/09:
Recalled 53 Platelets Leukocytes Reduced Products due to labeling (failure to properly label platelet products 'Donor took aspirin')

10/30/09:
Recalled 1 Fresh Frozen Plasma Pheresis Product due to donor eligibility (failure to defer t\No donors when an obsolete version of a reference for tattoos was utilized).

10/30/09:
Recalled 1 Platelets Pheresis Leukocytes Reduced Irradiate Product due to donor eligibility (failure to defer t\No donors when an obsolete version of a reference for tattoos was utilized).

10/30/09:
Recalled 1 Platelets Pheresis Leukocytes Reduced Product due to donor eligibility (failure to defer two donors when an obsolete version of a reference for tattoos was utilized).

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel in a Creutzfeldt Jacob Disease (CJD) risk area).

10/30/09:
Recalled 1 Platelets Product due to donor eligibility (failure to defer donor for travel in a Creutzfeldt Jakob Disease (CJD) risk area).

10/30/09:
Recalled 1 Recovered Plasma Product due to donor eligibility (failure to defer donor for travel in a Creutzfeldt Jakob Disease (CJD) risk area).

2/6/08:
Recalled 3 Fresh Frozen Plasma Products due to failure to control suspect blood component(s) (inappropriate release after discovering clots in red blood cells).

2/6/08:
Recalled 3 Cryoprecipitated AHF Products due to failure to control suspect blood component(s) (inappropriate release after discovering clots in red blood cells).

2/6/08:
Recalled 2 Platelets Leukocytes Products 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 Product due to donor eligibility (Blood Donation Record question related to ongoing medical conditions was unanswered).

2/6/08:
Recalled 1 Platelets Leukocytes Reduced Product due to donor eligibility (Blood Donation Record question related to ongoing medical conditions was unanswered).

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

Written standard operating procedures including all steps to be followed in the collection of blood and blood components for homologous transfusion are not always followed.

1.) Work Instruction 15.3.51. Determining the Need for Risk Management Notification. states that when a donor sought medical treatment as a result of a complication, the incident must be reported to the Risk Management Officer. Three cases, dated 4/22/2009, 6/30/2009, and 10/5/2009 involved donors visiting their personal physician after donating. Staff failed to document on the Donor Reaction and Injury Record that Risk Management was notified. The DRIR's dated 4/22/2009 and 6/30/2009 include both the Medical Director Signature and the Final Quality Review. The DRIR dated 10/5/2009 is missing both the Medical Director Signature and the Final Quality Review.

2.) Work Instruction 15.3.55, Performing Final Case and Donor Suitability Assessments, states that reviews for performing final case and donor suitability assessment need to be performed within a reasonable amount of time. Four Donor Reaction and Injury Records, dated 7/10/2009, 10/5/2009, 10/26/2009 and 11/25/2009 are all missing the Medical Director Review, Recommendation and Signature. These records are also missing the Final Quality Review.

Download the pdf file to read the complete inspection report.