Recall Z-1004-2025— Becton Dickinson & Co.

Name: FDA recall Z-1004-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-19

Class II · Ongoing

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2024-12-19. It names one FDA 510(k) clearance: K111860. Product: BD PCR Cartridges used with MAX System. Model Number: 437519. Reason: Potential for signal drift in specific lots of BD PCR Cartridges..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Ongoing
Initiated: 2024-12-19
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K111860 — BD MAX GBS ASSAY, BD MAX INSTRUMENTBecton, Dickinson & CO·cleared 2012-02-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.