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Recall Observatory FDA recall evidence

Device 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

Z-2548-2016

July 18, 2016

Class II

Product summary

Firm
Cepheid
Event
Event 74803
Status
Terminated
Classification
Class II
Quantity
68 kit for lot 1000037539 and 127 kit s for lot 1000029307.
Official record key
device-enforcement:Z-2548-2016

Official wording

Reason: Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.

Code information: Catalog number: GXMRSA-120, Rev. AJ; Lot numbers: 1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419).

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.