Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Xpert MRSA Catalog GXMRSA-120 Recalled by Cepheid Due to Internal investigation found the certain lots of MRSA...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cepheid directly.
Affected 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
Quantity: 68 kit for lot 1000037539 and 127 kit s for lot 1000029307.
Why Was This Recalled?
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
Where Was This Sold?
This product was distributed to 24 states: AZ, CA, CO, DE, FL, GA, IL, IN, ME, MD, MS, MO, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA
About Cepheid
Cepheid has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report