[Recalled] Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012. — Clot activating reagent mis-positioned or visibly absent in the cuvette's test… | FDA 2016-04-22
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012. |
|---|---|
| Brand / manufacturer | Accriva Diagnostics Inc., dba ITC, dba Accumetrics |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1720-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 22 April 2016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.