Reported Aug 24, 2016 · Terminated
Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System…
Cepheid
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cepheid · 904 E Caribbean Dr · Sunnyvale, CA · 94089-1189
Is this the product you have?
- Xpert MRSA Catalog GXMRSA-120, Rev
- AJ MicrobiologyThe Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for nasal colonization
- Lot codes and dates
- Catalog numberGXMRSA-120, Rev. AJ
- Lot numbers1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419)
- Amount recalled
- 68 kit for lot 1000037539 and 127 kit s for lot 1000029307.
Where it was sold
Why it was recalled
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
This product could cause temporary or reversible health problems — stop using it.
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