directCHECK ACT-LR whole blood quality control — Class II medical device recall Z-2460-2026
Ongoing recall by Accriva Diagnostics, Inc., reported 2026-06-24, distributed nationwide. Assayed Whole blood control contains labeling with incorrect performance range.
| Recall number | Z-2460-2026 |
|---|---|
| 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 | 2026-04-30 |
| Classified | 2026-06-16 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, ES, HK |
| Quantity | 6,060 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10711234170373 |
| Lot numbers | A6DLA001 |
| Model numbers | DCGLR-2 |
Product
directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2
Reason for recall
Assayed Whole blood control contains labeling with incorrect performance range.
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-2460-2026. 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.