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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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

Product Detail

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