Cepheid Recalls

5 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (5)

November 5, 2025
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Product testing did not meet expected stability criteria.
Class II
October 30, 2025
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.
Class II
October 30, 2025
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
Class II
August 6, 2025
Xpert 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 us
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
Class II
June 20, 2024
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 specimens, and/or delay to test results.
Class II

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