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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Product Detail

Product Description BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.
Recall Number Z-2319-2012
Classification Class II
Code Info Lot/ Exp. 08T11250 2012-07-06
Product Distributed Qty 32 kits
Reason For Recall Leakage in Cepheid SmartCycler reaction tubes.

Event Detail

Event Id 62505
Product Type Devices
Status Ongoing
Recalling Firm Becton Dickinson & Co.
City Sparks
State MD
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including CA, DE, FL, GA, IL, IN, KS, KY, ME, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TX, VA, WA, WI, and WV.
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