Recall Z-2320-2012— Becton Dickinson & Co.

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2012-05-22, terminated 2012-11-02. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Leakage in Cepheid SmartCycler reaction tubes..

Recalling firm

Becton Dickinson & Co.

Classification

Class II

Status

Terminated

Initiated

2012-05-22

Terminated

2012-11-02

Firm location

Sparks, MD, United States

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