Cepheid recalls
5 official recalls and safety alerts involving Cepheid since 2023-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Cepheid or the relevant agency.
- 2025-12-24
USCepheid recalls Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
FDA · DeviceCepheidUS: AL AR AZ CA CO FL GA IA IL KS KY LA MD ME MI MN MO NC NE NH NJ NY OH PA RI…Official notice →- 2025-12-03
- US
Cepheid recalls Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Product testing did not meet expected stability criteria.
- 2025-11-05
- US
Cepheid recalls Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of…
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
FDA · DeviceCepheidU.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice → - 2024-08-21
- US
Cepheid recalls Cepheid, Sample Collection Device, Part: 900-0370
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…
FDA · DeviceCepheidWorldwide distribution: US (nationwide): IL, TX, OH, LA, NY, CA, MD, IA, MN,…Official notice → - 2023-11-08
- US
Cepheid recalls Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,
pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results or no result test results.
FDA · DeviceCepheidWorldwide distribution - US Nationwide and the countries of Costa Rica,…Official notice →