Z-2548-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 24, 2016
- Initiation Date
- July 18, 2016
- Termination Date
- September 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 68 kit for lot 1000037539 and 127 kit s for lot 1000029307.
Product Description
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
Reason for Recall
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
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.
Code Information
Catalog number: GXMRSA-120, Rev. AJ; Lot numbers: 1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419).