FDA-Device2016-08-24Class II
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
Cepheid
Hazard
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
Sold states
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.
Affected count
68 kit for lot 1000037539 and 127 kit s for lot 1000029307.
Manufactured in
904 E Caribbean Dr, N/A, Sunnyvale, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2548-2016Don't want to check this manually?
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