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
- Company
- Cepheid
- Recall Initiated
- July 18, 2016
- Terminated
- September 30, 2016
- Recall Number
- Z-2548-2016
- Quantity
- 68 kit for lot 1000037539 and 127 kit s for lot 1000029307.
- Firm Location
- Sunnyvale, CA
Reason for Recall
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
Distribution
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.
Lot / Code Info
Catalog number: GXMRSA-120, Rev. AJ; Lot numbers: 1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419).
Root Cause
Nonconforming Material/Component
Action Taken
Recall letters dated July 18, 2016 were sent to affected customers on July 19, 2016 by Federal Express. Letters advised users of the affected product and asked that any remaining inventory be destroyed.
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