FDA Device recall Z-2460-2026
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
- FDA Device
- Class II
- ongoing
- Published 2026-06-24
On 2026-06-24 the FDA classified a Class II recall of directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2 by Accriva Diagnostics, citing assayed Whole blood control contains labeling with incorrect performance range.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2460-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-30 |
| Published | 2026-06-24 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Accriva Diagnostics |
| Distribution | US |
Product
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Reason
Assayed Whole blood control contains labeling with incorrect performance range.
Identifiers
| code_info | Lot #: A6DLA001 Unique Device Identifier: 10711234170373 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2460-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.