Descriptions of reasons or recalls
| Recall reason . | Definition . | Example citation in enforcement reports . | Proportion of recall events, % (n/N) . |
|---|---|---|---|
| Contamination | Contamination of the blood product during manufacturing and distribution; a contaminant is identified | Blood product possibly contaminated with bacteria | 2 (93/4700) |
| Donor related | Issues relating to the quality of donated blood | Donor suitability was not adequately determined | 60 (2819/4700) |
| Manufacturing defect | Defect directly attributed to blood manufacturing | Blood product manufactured without additive solution | 2 (91/4700) |
| Misbranding | Blood products are labeled incorrectly | Blood product incorrectly labeled as negative for the JKA red cell antigen | 7 (307/4700) |
| Product specs not met | Blood products did not meet acceptable product specifications | Blood product had low platelet count | 12 (586/4700) |
| QC unacceptable | Quality checks for testing and processing were not conducted | Required HIV/HCV nucleic acid test not performed | 13 (616/4700) |
| Sterility of facility | Equipment, procedures, or facilities were ineffective in maintaining sterility of blood products; no specific contaminant was identified. | Blood products were collected in a manner that may have compromised the sterility of the collection system | 4 (188/4700) |
| Recall reason . | Definition . | Example citation in enforcement reports . | Proportion of recall events, % (n/N) . |
|---|---|---|---|
| Contamination | Contamination of the blood product during manufacturing and distribution; a contaminant is identified | Blood product possibly contaminated with bacteria | 2 (93/4700) |
| Donor related | Issues relating to the quality of donated blood | Donor suitability was not adequately determined | 60 (2819/4700) |
| Manufacturing defect | Defect directly attributed to blood manufacturing | Blood product manufactured without additive solution | 2 (91/4700) |
| Misbranding | Blood products are labeled incorrectly | Blood product incorrectly labeled as negative for the JKA red cell antigen | 7 (307/4700) |
| Product specs not met | Blood products did not meet acceptable product specifications | Blood product had low platelet count | 12 (586/4700) |
| QC unacceptable | Quality checks for testing and processing were not conducted | Required HIV/HCV nucleic acid test not performed | 13 (616/4700) |
| Sterility of facility | Equipment, procedures, or facilities were ineffective in maintaining sterility of blood products; no specific contaminant was identified. | Blood products were collected in a manner that may have compromised the sterility of the collection system | 4 (188/4700) |
QC, quality control.