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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog number: GXMRSA-120, Rev. AJ; Lot numbers: 1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419).
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Cepheid
- Reason for Recall:
- Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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
Product Codes/Lot Numbers:
Catalog number: GXMRSA-120, Rev. AJ; Lot numbers: 1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419).
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2548-2016
Related Recalls
Product testing did not meet expected stability criteria.
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure, cross contamination causing false positive results for other specimens, and/or delay to test results.