Tuberculosis test cartridges recalled after failing expected stability criteria
Cepheid is recalling 9,880 Xpert MTB/RIF cartridges from one lot because product testing did not meet expected stability criteria.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites a stability specification failure without describing an erroneous result or any reported harm.
Plain-English summary
The Cepheid Xpert MTB/RIF, model GXMTB/RIF-US-10, is being recalled.
Product testing did not meet expected stability criteria.
The recall covers 9,880 units carrying UDI-DI 07332940000912, from batch 1000812229, lot 41302. The product was distributed nationwide in the United States and in Puerto Rico. The FDA has classified the action as Class II.
The enforcement record states the stability failure without describing a testing consequence or reporting injuries. Laboratories holding the affected lot should follow Cepheid's instructions.
The recalled product
- Product
- Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
- Manufacturer
- Cepheid
- Category
- Medical Device — Diagnostic test
- Hazard
- stability-failure
- out-of-specification
Distribution
Distributed nationwide across the United States.
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