FDA recall record · openFDA

Cepheid

7 FDA recalls on record (2023–2025) — 7 device. 7 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurat 2

pipettes packaged in Strep A test may fail to dispense an adequate sample volume which could result in "invalid" results 2

Product testing did not meet expected stability criteria. 1

Specimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could r 1

As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample ty 1

Recalls

Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 Class II 2025-10-30 Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. Class II 2025-11-05 Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 Class II 2025-10-30 Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 tes Class II 2025-08-06 Cepheid, Sample Collection Device, Part: 900-0370 Class II 2024-06-20 Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD, Class II 2023-04-24 Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only Class II 2023-04-24

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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