Quick Facts at a Glance
- Recall Date
- November 5, 2025
- Hazard Level
- HIGH
- Brand
- Cepheid
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Cepheid
- Product type
- Molecular diagnostic instrument
- Model numbers
- GXMTB/RIF-US-10
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 5, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Product testing did not meet expected stability criteria.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cepheid or your healthcare provider for instructions. Notification method: Letter
About This Product
The Xpert MTB/RIF GXMTB/RIF-US-10 is a Cepheid molecular diagnostic instrument used for rapid tuberculosis testing in clinical settings.
Why This Is Dangerous
The hazard arises from stability criteria not being met during testing, which may affect device performance.
Industry Context
This recall is not described as part of a broader industry pattern in the provided notice.
Real-World Impact
The notification affects healthcare facilities using the GXMTB/RIF-US-10, potentially impacting test stability and reliability until resolved.
Practical Guidance
How to identify if yours is affected
- Verify model GXMTB/RIF-US-10 on the device label.
- Confirm quantities match 9,880 units distributed in US and Puerto Rico.
Where to find product info
Recall notices and instructions are published by Cepheid and the FDA enforcement database linked in the recall notice.
What timeline to expect
Refunds or replacements are typically processed within 4-8 weeks, subject to Cepheid procedures.
If the manufacturer is unresponsive
- Escalate through hospital or lab management
- File a complaint with relevant regulatory bodies if Cepheid is unhelpful
- Consult legal counsel if necessary
How to prevent similar issues
- Maintain up-to-date recall subscriptions from Cepheid and FDA.
- Verify device model numbers before deployment or re-ordering.
- Implement inventory controls to quickly isolate affected lots or batches.
Documentation advice
Keep all recall communications, serial numbers, shipment records, and correspondence with Cepheid.
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Product Details
Model: GXMTB/RIF-US-10 UDI-DI: 07332940000912 Batch: 1000812229 Lot: 41302 Expiration Date: 2025-02-02 Quantity: 9,880 units Distribution: US nationwide and Puerto Rico Recall Date: 2025-11-05 Status: ACTIVE Manufacturer: Cepheid
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model GXMTB/RIF-US-10
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Safety Guide
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