RecallWatchUSA

Home / Recalls / Medical Devices

Becton Dickinson & Co. recalls BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du

Recalled September 12, 2012 · FDA recall Z-2317-2012 · Becton Dickinson &

Hazard
Leakage in Cepheid SmartCycler reaction tubes. · FDA Class II
Units
68 kits
Sold at
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.

Description

Leakage in Cepheid SmartCycler reaction tubes.

Product
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. .
Manufacturer(s)
Becton Dickinson & Co.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Becton Dickinson & Co. recalls BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du | RecallWatchUSA