Reported Jan 21, 2026 · Ongoing
The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring…
Instrumentation Laboratory
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Instrumentation Laboratory · 180 Hartwell Rd · Bedford, MA · 01730-2443
Is this the product you have?
- The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
- Lot codes and dates
- Part Number0020006800
- UDI-DI08426950078920
- Lot NumberN1136730. Expiration Date 12/31/2025
- Amount recalled
- 7,720 units
Where it was sold
Why it was recalled
Potential for microbial contamination.
This product could cause temporary or reversible health problems — stop using it.
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