BD PCR Cartridges used with MAX System. Model Number: 437519

FDA device recall Z-1004-2025 · posted 2025-01-21 · Open, Classified

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NJR

Quantity affected

516,435 units

Distribution

Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK

Date initiated

2024-12-19

Date posted

2025-01-21

Location

Sparks, MD

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