Device product
BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 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.
Z-2316-2012
Product summary
- Event
- Event 62505
- Status
- Terminated
- Classification
- Class II
- Quantity
- 38 kits
- Official record key
device-enforcement:Z-2316-2012
Official wording
Reason: Leakage in Cepheid SmartCycler reaction tubes.
Code information: Lot/Exp date: 03T11346Z 2012-06-11, 03T12034 2012-07-31
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.
Derived failure modes
-
Unknown
Leakage in Cepheid SmartCycler reaction tubes.