Becton Dickinson & Co.: Medical Device Recall in 2013 - (Recall #: Z-0976-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 11, 2012

Date Posted: April 3, 2013

Recall Number: Z-0976-2013

Event ID: 64310

Reason for Recall:

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

Status: Terminated

Product Quantity: 27 boxes/648 cartridges

Code Information:

Lot/Exp. date: 2235001 2014-08-22

Distribution Pattern:

Worldwide Distribution - USA including CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI and the country of Belgium

Voluntary or Mandated:

Voluntary: Firm initiated