FDA Device recall Z-0880-2026
Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagu…
- FDA Device
- Class II
- ongoing
- Published 2025-12-10
On 2025-12-10 the FDA classified a Class II recall of Hemochron Activated Clotting Time Low-Range Test Cuvette, REF: ACT-LR, to be used with the Hemochron Signature ELITE Whole Blood Microcoagu… by Accriva Diagnostics, citing 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 h….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0880-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-05 |
| Published | 2025-12-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Accriva Diagnostics |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI-DI: 10711234103081. Lot: E5JLR132. Expiration: 08-31-2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0880-2026%22
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