Recall Z-0317-2027 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Accriva Diagnostics, Inc.
Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103
| Date | Oct 30, 2026 (initiated Sep 14, 2026) |
| Status | Open, Classified |
| 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 |
| Action | On 9/14/2026, recall notices were mailed to customers who were informed of the following: 1) Please forward this communication to those within your organization who need to be aware of this matter and verify they understand the procedure and can complete the enclosed forms. 2) Forward the enclosed customer notification to all other organizations where affected devices may have been transferred to. 3) Please check your inventory and do not use affected lots. 4) Scrap/destroy all impacted cuvettes and/or boxes. 5) Complete and return the Acknowledgement and Receipt Form via email to ilsd_ra.na@w |
| Quantity | 28710 |
| Distribution | Worldwide - US Nationwide distribution in the states of MA, MO, AK, WV, NJ, TX, VA, IL, NY and the countries of China, Colombia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940401 | JR. MICROCOAGULATION SYSTEM International Technidyne Corp., May 11, 1994 |