Recall Z-0880-2026 ยท JBP Activated Whole Blood Clotting Time
Accriva Diagnostics, Inc.
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
| Date | Dec 3, 2025 (initiated Nov 5, 2025) |
| Status | Open, Classified |
| Reason | Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling. |
| Root cause | Packaging process control |
| Action | On 11/5/2025, recall notices were mailed to Medical Directors, Lab Directors, Clinical Laboratory Managers, or Point of Care Coordinators who were asked to do the following: 1) Forward this communication to those within your organization who need to be aware 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. 3) Please check your inventory for affected devices. If you find any, please refrain from opening any pouches or using the product. Destroy |
| Quantity | 20250 |
| Distribution | Worldwide - US Nationwide distribution including in the states of OH, IL, NY, GA, CA, IN, NJ, TX, KS, NE, FL, SC, MO, WV, WA, MI, CO, TN, PA, UT, LA, MT, NC, KY, TX and the countries of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K960749 | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT International Technidyne Corp., Aug 12, 1996 |