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Cepheid FDA Recalls
7 recalls on file across devices, 0 of them Class I and 7 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.Class IINov 5, 2025Product testing did not meet expected stability criteria. |
| Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10Class IIOct 30, 2025Invitro diagnostic test kits with specimens that have elevat |
| Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10Class IIOct 30, 2025Invitro diagnostic test kits with specimens that have elevat |
| Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 tesClass IIAug 6, 2025As a result of Post-Market half-time stability testing, fals |
| Cepheid, Sample Collection Device, Part: 900-0370Class IIJun 20, 2024Specimen collection device may leak after the patient sample |
| Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx OnlyClass IIApr 24, 2023pipettes packaged in Strep A test may fail to dispense an ad |
| Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,Class IIApr 24, 2023pipettes packaged in Strep A test may fail to dispense an ad |