Cepheid
Diagnostics makerAI in United StatesAI, part of DanaherAI. FDA records under 3 spellings of its name, each linked to the record.
- 510(k) clearances: 63
- Device recalls: 12
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Nov 5, 2025 | Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.Class II · Product testing did not meet expected stability criteria. | Device recalls |
| Oct 30, 2025 | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10Class II · Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurat | Device recalls |
| Oct 30, 2025 | Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10Class II · Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurat | Device recalls |
| Aug 6, 2025 | Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection Class II · As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample ty | Device recalls |
| Jun 20, 2024 | Cepheid, Sample Collection Device, Part: 900-0370Class II · Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could r | Device recalls |
| Apr 24, 2023 | Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,Class II · pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results | Device recalls |
| Apr 24, 2023 | Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx OnlyClass II · pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results | Device recalls |
| Oct 9, 2017 | Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/Class II · Cepheid has received reports that some of our customers have experienced a higher number of temperature drift errors th | Device recalls |
Canada and Imports
Matched by company name- Active Health Canada device licences
- 25, as of Nov 10, 2026
Names and Identifiers
- Appears as
- Website
- cepheid.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built