FDAJuly 18, 2016device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
What to do
FDA enforcement status: Terminated
Brands named
cepheid
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAXpert MTB/RIF. Model Number: GXMTB/RIF-US-10.2025-11-05
- FDABrand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-102025-10-30
- FDABrand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-102025-10-30
- FDAXpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of reagents and other associated materials intended to be used for the direct qualitative and/or quantitative detection of nucleic acid from methicillin-resistant...2025-08-06
- FDACepheid, Sample Collection Device, Part: 900-03702024-06-20
- FDAXpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,2023-04-24
- FDAXpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only2023-04-24
- FDAXpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. Is a qualitative in vitro real-time PCR test.2017-10-09
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