Cepheid
7 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Cepheid and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-12-24FDA-DeviceClass IICheck Cepheid BCR-ABL Ultra test lot numbers
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
- 2025-12-24FDA-DeviceClass IICheck Cepheid BCR-ABL test kit lot numbers
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
- 2025-12-03FDA-DeviceClass IIXpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Product testing did not meet expected stability criteria.
- 2025-11-05FDA-DeviceClass IIXpert 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 and methicillin-susceptible Staphylococcus aureus (MRSA/MSSA) bacteria present in a clinical specimen, using a nucleic acid technique
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
- 2024-08-21FDA-DeviceClass IICepheid, 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 specimens, and/or delay to test results.
- 2023-11-08FDA-DeviceClass IIXpert 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.
- 2023-11-08FDA-DeviceClass IIXpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only
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.
Get notified about new Cepheid recalls
Free weekly digest. We email when a new federal recall affects Cepheid or anything else in your household.
Get the Sunday Brief