Accriva Hemochron Jr. APTT cuvettes recalled for inaccurate results
Accriva Diagnostics is recalling certain Hemochron Jr. APTT test cuvettes, used to check low-dose heparin levels in blood. The clot-activating reagent inside some cuvettes may be out of position or missing, which can cause error codes or falsely high results. Falsely high results could lead to a lower anticoagulant dose than needed, which could raise the risk of blood clots. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Accriva Diagnostics recalls
What to do
- Check cuvette lot numbers against the recall list: B6JCA005, C6JCA007, C6JCA008, D6JCA011, K5JCA041.
- Stop using cuvettes from the affected lots and follow your facility's procedures for quarantine.
- Contact Accriva Diagnostics for guidance on next steps and any replacement.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 28710
- Illnesses reported
- None reported
- Manufactured in
- 6260 Sequence Dr, San Diego, California, United States
- Classification
- Class II
- Recall number
- Z-0317-2027
In the FDA's words
- Description
- Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103 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. UDI-DI: 10711234103012, Lot(Expiration): B6JCA005(02/28/2027), C6JCA008(03/31/2027), D6JCA011(04/30/2027), K5JCA041(10/31/2026), C6JCA007(03/31/2027) Distribution: Worldwide - US Nationwide distribution in the states of MA, MO, AK, WV, NJ, TX, VA, IL, NY and the countries of China, Colombia. Affected quantity: 28710
- Hazard
- 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.