Device recall
Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103
- Recall number
- Z-0317-2027
- Event id
- 99863
- Status
- Open, Classified
- FDA classification
- Class II
- Recalling firm
- Accriva Diagnostics, Inc.
- Posted
- Oct 30, 2026
- Initiated
- Sep 14, 2026
- Product code
- JPA
- Device type
- System, Multipurpose For In Vitro Coagulation Studies
- Reason
- 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.
- Root cause
- Process control
- Quantity
- 28710
- Code info
- 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.
- Related 510(k)s
- K940401
- Location
- San Diego, CA