FDAOctober 9, 2017device
Xpert 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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors than would typically be expected when using this test and its intended use specimen types. Investigation of the issue also revealed an occasional probability of false negative results which remains consistent with package insert claims.
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 EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individuals with signs and sym...2017-09-15
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