BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartrid...

FDA Recall #Z-0976-2013 — Class II — December 11, 2012

Recall #Z-0976-2013 Date: December 11, 2012 Classification: Class II Status: Terminated

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.

Reason for Recall

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

Recalling Firm

Becton Dickinson & Co. — Sparks, MD

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

27 boxes/648 cartridges

Distribution

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

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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