FDA Device recall Z-1720-2016
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012
- FDA Device
- Class II
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class II recall of Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012 by Accriva Diagnostics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1720-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-22 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Accriva Diagnostics |
| Distribution | VA |
Product
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
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.
Identifiers
| code_info | Lot #B6JCA012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1720-2016%22
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