In the agency's Nov 11, 2026 enforcement report · Ongoing
Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103
Accriva Diagnostics, Inc.
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: Accriva Diagnostics, Inc. · 6260 Sequence Dr · San Diego, CA · 92121-4358
Is this the product you have?
- Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette
- REFJ103
- Lot codes and dates
- UDI-DI10711234103012
- Lot(Expiration)
B6JCA005(02/28/2027)C6JCA008(03/31/2027)D6JCA011(04/30/2027)K5JCA041(10/31/2026)C6JCA007(03/31/2027)
- Amount recalled
- 28710
Where it was sold
Why it was recalled
Microcoagulation test used to evaluate low dose heparin anticoagulation has a mispositioned or absent clot activating reagent, which may result in out-of-range high error code, or erroneously high results, which may lead retest, or overestimation of patient's anticoagulation, leading to inadequate anticoagulant therapy, which could result in thrombosis.
This product could cause temporary or reversible health problems — stop using it.
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