Class II — Accriva Diagnostics Inc., dba ITC, dba Accumetrics
| Recalling firm | Accriva Diagnostics, Inc. |
|---|---|
| Registered facility | Accriva Diagnostics, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result. |
| Product | Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012. |
| Quantity | 135 boxes |
| Distribution | U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany. |
| Initiated | 2016-04-22 |
| Classified | 2016-05-25 |
| Terminated | 2016-12-14 |
| Recall number | Z-1720-2016 |
| 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., dba ITC, dba Accumetrics (Z-1720-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73949/
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