Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Reported: December 3, 2025 Initiated: November 5, 2025 #Z-0724-2026
Product Description
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Reason for Recall
Product testing did not meet expected stability criteria.
Details
- Recalling Firm
- Cepheid
- Units Affected
- 9,880 units
- Distribution
- US Nationwide distribution and Puerto Rico.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.. Recalled by Cepheid. Units affected: 9,880 units.
Why was this product recalled? ▼
Product testing did not meet expected stability criteria.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 3, 2025. Severity: Moderate. Recall number: Z-0724-2026.
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