Device product
Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The 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
Z-2548-2016
Product summary
- Firm
- Cepheid
- Event
- Event 74803
- Status
- Terminated
- Classification
- Class II
- Quantity
- 68 kit for lot 1000037539 and 127 kit s for lot 1000029307.
- Official record key
device-enforcement:Z-2548-2016
Official wording
Reason: Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
Code information: Catalog number: GXMRSA-120, Rev. AJ; Lot numbers: 1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419).
Distribution pattern: US only: PA, DE, FL, SC, ME, CA, IL, NC, TX, WA, NY, TN, FL, OR, OK, MO, MS, GA, NM, IN, OH, MD, VA, CO, AZ, and NC.
Derived failure modes
-
Unknown
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.