The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 11, 2025 |
| Reported | January 21, 2026 |
| Recalling firm | Instrumentation Laboratory |
| Country / region | United States MA |
Hazard
Potential for microbial contamination.
Affected products
- The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
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