Medical Device Recalls - How Laboratories Must Respond

The laboratory director has a legal obligation to follow-up with all recalls that impact any test components or blood components used in the laboratory. While blood bankers are already on high alert for all blood component recalls, the impact from a medical device recall can be just as serious as a blood component recall. Per the CAP laboratory general checklist (GEN.20340), the laboratory manages notifications from vendors of defects or issues with reagents, supplies, instruments, equipment, or software that may affect patient care/client services. For example, there was a recent recall on waived blood lead testing lot numbers. The recall was classified as level I because use of the impacted lot numbers might have led to falsely low lead results. In this CAPcast, Matthew Krasowski, MD, FCAP, Chair of the CAP Toxicology Committee, discusses the laboratory’s role in medical device recall, such as this recent incident, and how both CAP accredited laboratories and inspectors should respond to recalls.