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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Product Detail

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.
Recall Number Z-0976-2013
Classification Class II
Code Info Lot/Exp. date: 2235001 2014-08-22
Product Distributed Qty 27 boxes/648 cartridges
Reason For Recall Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.

Event Detail

Event Id 64310
Product Type Devices
Status Ongoing
Recalling Firm Becton Dickinson & Co.
City Sparks
State MD
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA including CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI and the country of Belgium
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