Accriva- APTT Cuvette for use on the Hemochron Jr — Class II medical device recall Z-1720-2016
Terminated recall by Accriva Diagnostics Inc., dba ITC, dba Accumetrics, reported 2016-06-01. Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to ei
| Recall number | Z-1720-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accriva Diagnostics Inc., dba ITC, dba Accumetrics, San Diego, CA, United States |
| Recall initiated | 2016-04-22 |
| Classified | 2016-05-25 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2016-12-14 |
| Countries outside the US | CN, DE, IT |
| Quantity | 135 boxes |
| Lot numbers | B6JCA012 |
| Model numbers | J103 |
Product
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
Reason for recall
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.
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-1720-2016. 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.