[pending] Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
Pending LLM rewrite. Source: FDA_DEVICE Z-0724-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Product testing did not meet expected stability criteria.
The recalled product
- Product
- Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
- Manufacturer
- Cepheid
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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