Hemochron Activated Clotting Time Low-Range Test Cuvette — Class II medical device recall Z-0880-2026
Ongoing recall by Accriva Diagnostics, Inc., reported 2025-12-10, distributed nationwide. Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has s
| Recall number | Z-0880-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accriva Diagnostics, Inc., San Diego, CA, United States |
| Recall initiated | 2025-11-05 |
| Classified | 2025-12-03 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 20,250 |
| Reason classes | foreign material, potency |
| UPC / GTIN / UDI-DI | 10711234103081 |
| Lot numbers | E5JLR132 |
| Expiration dates | 2026-08-31 |
Product
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagulation System
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0880-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.