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Cepheid recalls Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx S
Recalled August 24, 2016 · FDA recall Z-2548-2016 · Cepheid
Hazard
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations. · FDA Class II
Units
68 kit for lot 1000037539 and 127 kit s for lot 1000029307.
Sold at
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.
Description
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
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
Manufacturer(s)
Cepheid
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →