Cepheid
7 federal recalls on file, showing the 4 from the last 12 months. 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
Cepheid's Xpert BCR-ABL Ultra diagnostic test kits may produce inaccurate results when testing blood samples with very high white blood cell counts (above 30,000 cells). This affects certain lot numbers distributed across the US and internationally. No injuries have been reported.
- 2025-12-24FDA-DeviceClass IICheck Cepheid BCR-ABL test kit lot numbers
Cepheid's Xpert BCR-ABL Ultra diagnostic test kits may give inaccurate results when testing blood samples with very high white blood cell counts (over 30,000 cells). This affects specific lot numbers distributed across the US and internationally. No injuries have been reported.
- 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.
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