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Recalls and Significant Blood Safety Violations

10/30/09:
Reviewer observed that a collection trip scale was not identified as having been subjected to a required quality control function check. The scale was used to collect five whole blood units. The reviewer failed to gain control of the units or associated components.

10/30/09:
FDA discovered that ARC had not thoroughly investigated a system-wide problem related to entering incorrect donor gender into its electronic blood donation records system. The entry of incorrect donor gender resulted in an undetermined number of problems and distribution of an unknown number of blood components that were collected from donors whose suitability to donate had not been properly evaluated.

10/30/09:
Moderate risk problems were discovered on for separate occasions when a donor returned and it became apparent that incorrect gender-specific health history questions were asked on the previous donation. In total, eight blood components from these donations were distributed and recalled by ARC.

10/30/09:
Recalled 2 Platelets Pheresis Leukocytes Reduced Products due to collection (products collected using apheresis kits that had exceed the acceptable time period for use).

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 Platelets Pheresis Leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a malarial risk area).

10/30/09:
Recalled 1 Platelets Pheresis leukocytes Reduced Product due to donor eligibility (failure to defer donor for travel to a malarial risk area).

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product 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 Plasma Frozen 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 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 3 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 Platelets Pheresis Leukocytes Reduced Product due to collection (products collected using apheresis kits that had exceed the acceptable time period for use).

10/30/09:
Recalled 10 Cryoprecipitated AHF Products due to component preparation (failure to freeze blood components within the required one hour following manufacture).

10/30/09:
Recalled 1 Platelets Pheresis Leukocytes Reduced Irradiated Products due to component preparation (irradiation not performed in accordance with specifications).

10/30/09:
Recalled 118 Cryoprecipitated AHF Products due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09:
Recalled 84 Red Blood Cells Products due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09:
Recalled 229 Red Blood Cells Leukocytes Reduced Products due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09:
Recalled 17 Plasma Frozen Products due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09:
Recalled 8 Red Blood Cells Leukocytes Reduced Irradiated Products due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09:
Recalled 71 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 (failure to defer donor for travel in a CJD risk area).

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

10/30/09:
Recalled 2 Recovered Plasma Products due to donor eligibility (failure to defer donor for travel in a CJD risk area).

10/30/09:
Recalled 2 Red Blood Cells Products due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09:
Recalled 9 Red Blood Cells Leukocytes Reduced Products due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09:
Recalled 1 Cryoprecipitated AHF Product due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09:
Recalled 1 Cryoprecipitated AHF Pooled Product due to collection (inadequate arm prep; sterility may have been compromised).

10/30/09:
Recalled 1 Frozen Plasma Product 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 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). Food and Drug Administration Adverse Determination Letter (ADL)

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

Failure to provide adequate space for private examinations of individuals to determine their suitability as blood donors.

Specifically, privacy was not maintained when employee "[REDACTED TEXT]" screened Donor #[REDACTED TEXT] While standing outside the screening booth and beside the donor collection area, I could hear "[REDACTED TEXT]" read the screening questions to Donor #[REDACTED TEXT] and I could hear Donor #[REDACTED TEXT] respond to the screening questions.

Download the pdf file to read the complete inspection report.

The following excerpt is from page 4 of this 11-page FDA Inspection Report:

The following concerns and/or complaints were received through the Blood Drive Sponsor Satisfaction Survey forms; however, the information was not evaluated or investigated as a concern or a complaint:

1. 11/4/2009 blood drive. The drive coordinator reported in part, a regular donor was sprayed with blood " ... on a yellow shirt and face ... ".
2. 11/6/2009 high school blood drive. The drive coordinator reportedly was dissatisfied with staffing levels to meet the needs of the drive. According to the operations report the staffing level was deficient according to the firm's staffing matrix.
3. 11/13/2010 church blood drive. The drive coordinator reported the following: " ... Between 3: 15 & 4: 15 the staff disappeared. 2 out of 10 beds were being used and the hallway was full of donors waiting. There was an obvious rif/tension among the staff .... ". According to the operations report the staffing level was deficient according to the firm's staffing matrix.
4. 1/12/2010 church blood drive. The drive coordinator reportedly was very dissatisfied with staffing levels to meet the needs ofthe drive. The coordinator also reported that, " ... some people waited [REDACTED TEXT] hrs." According to the operations report, the staffing level was deficient according to the firm's staffing matrix.
5. 12/11/2009 blood drive. The drive coordinator reported, in part, " ... Please send staff who can do better sticks .... One employee had ... do stick and blood wasn't flowing fast so ... pushed needle in more. After 19 minutes bag wasn't full, so took blood and pitched ... Another Employee said they dug around before they found the vein .... ".

Download the pdf file to read the complete inspection report.