FDAJune 20, 2024device
Cepheid, Sample Collection Device, Part: 900-0370
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Ongoing
Brands named
cepheid
UPCs
28053326001523
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
- FDAXpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only2023-04-24
- FDAXpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,2023-04-24
- 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
- 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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