Class II — Accriva Diagnostics, Inc.
| Recalling firm | Accriva Diagnostics, Inc. |
|---|---|
| Registered facility | Accriva Diagnostics, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Assayed Whole blood control contains labeling with incorrect performance range. |
| Product | directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2 |
| Quantity | 6060 |
| Distribution | Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Canada, Hong Kong, Spain. |
| Initiated | 2026-04-30 |
| Classified | 2026-06-16 |
| Recall number | Z-2460-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Accriva Diagnostics, Inc. (Z-2460-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98979/
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