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
Reported: August 24, 2016 Initiated: July 18, 2016 #Z-2548-2016
Product 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
Reason for Recall
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
Details
- Recalling Firm
- Cepheid
- Units Affected
- 68 kit for lot 1000037539 and 127 kit s for lot 1000029307.
- Distribution
- 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.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cepheid. Units affected: 68 kit for lot 1000037539 and 127 kit s for lot 1000029307..
Why was this product recalled? ▼
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 24, 2016. Severity: Moderate. Recall number: Z-2548-2016.
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