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Z-2320-2012 Class II Terminated

Recalled by Becton Dickinson & Co. — Sparks, MD

FDA device recall Z-2320-2012 was initiated by Becton Dickinson & Co. on May 22, 2012 and is designated Class II. Reason for recall: Leakage in Cepheid SmartCycler reaction tubes. The recall status is terminated (terminated Nov 2, 2012). Affected quantity: 5 kits.

Recall Details

Product Type: Devices
Report Date: Sep 12, 2012
Initiation Date: May 22, 2012
Termination Date: Nov 2, 2012
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 5 kits

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.

Reason for Recall

Leakage in Cepheid SmartCycler reaction tubes.

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.

Code Information

Lot/ Exp. 05T11042 2012-04-30 (ONLY SOLD IN EUROPE)

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2320-2012
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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