CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report
Xpert MTB/RIF recalled by Cepheid
Cepheid is recalling Xpert MTB/RIF, distributed nationwide in the US. The recall was initiated on 5 Nov 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0724-2026
- FDA event ID
- 97911
- Recalling firm
- Cepheid, Sunnyvale, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Nov 2025
- FDA classified
- 26 Nov 2025
- Reported
- 3 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 5 Nov 2025 | Recall initiated by company | |
| 26 Nov 2025 | Classified by FDA | +21 days |
| 3 Dec 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product testing did not meet expected stability criteria.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Where it was distributed
US Nationwide distribution and Puerto Rico.
Questions about this recall
Why was it recalled?
Product testing did not meet expected stability criteria.
Which lots are affected?
Model Number: GXMTB/RIF-US-10. UDI-DI: 07332940000912. Batch: 1000812229. Lot: 41302. Expiration Date: 2025-02-02
Where was it sold?
US Nationwide distribution and Puerto Rico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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