Accriva Diagnostics, Inc.: System, Multipurpose For In Vitro Coagulation Studies
- Recalling firm
- Accriva Diagnostics, Inc.
- Product
- Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103
- 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.
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-14
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution in the states of MA, MO, AK, WV, NJ, TX, VA, IL, NY and the countries of China, Colombia.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/12584be6-7c9e-40f0-9ff1-e70cc708e8aa