BD PCR Cartridges (Becton Dickinson) – Signal Drift Risk (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Potential for signal drift in specific lots of BD PCR Cartridges.

Recommended Action

Per FDA guidance

BD notified consignees via email and mail on about 12/19/2024 with a letter titled, URGENT: Medical Device Product Correction. Consignees were informed regarding when they can and cannot use the affected BD PCR Cartridges. They were instructed to inspect inventory for affected cartridges, ensure the recall notification is read and understood by all affected personnel, to provide the notification to all affected personnel and customers if further distributed, to complete and return the Customer Response Form, and to report any adverse events associated with the affected units. Distributors were provided the same information and instructions, but were also instructed to provide a copy of the letter to their customers.