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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 VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***. The BD GeneOhm VanR Assay is a qualitative in vitro test for the rapid detection of vancomycin-resistance (vanA and vanB) genes directly from perianal or rectal swabs. The BD GeneOhm VanR Assay detects the presence of the vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). The assay is performed on an automated real-time PCR instrument with perianal or rectal swabs from individuals at risk for VRE colonization. The BD GeneOhm VanR Assay can be used as an aid to identify, prevent and control vancomycin-resistant colonization in healthcare settings. The BD GeneOhm VanR Assay is not intended to diagnose VRE infections nor to guide or monitor treatment for VRE infections. Concomitant cultures are necessary to recover organisms for epidemiological typing, susceptibility testing and for further confirmatory identification.
Recall Number Z-2320-2012
Classification Class II
Code Info Lot/ Exp. 05T11042 2012-04-30 (ONLY SOLD IN EUROPE)
Product Distributed Qty 5 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.