Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BD MAX PCR Cartridges Catalog #437519 Recalled by Becton Dickinson & Co. Due to Cartridges are not sealing properly during PCR testing...

Date: December 11, 2012
Company: Becton Dickinson & Co.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Becton Dickinson & Co. directly.

Affected Products

BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System.

Quantity: 27 boxes/648 cartridges

Why Was This Recalled?

Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.

Where Was This Sold?

This product was distributed to 11 states: CA, FL, IL, IN, KS, NY, OH, OR, PA, TX, WI

Affected (11 states)Not affected

About Becton Dickinson & Co.

Becton Dickinson & Co. has 183 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report