FDAFDA · Food and drugs·Recall number Z-2317-2012
BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. Test is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections nor to guide or monitor treatment for MRSA infections. .
Published September 12, 2012 · Recall initiated: May 22, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Leakage in Cepheid SmartCycler reaction tubes.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton Dickinson & Co.
- Distributor
- 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.
- Lot
- Lot/ Exp. 03T11345ZU 2012-07-09
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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