The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test
Pending LLM rewrite. Source: FDA_DEVICE Z-1095-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Potential for microbial contamination.
The recalled product
- Product
- The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
- Manufacturer
- Instrumentation Laboratory
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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