Accriva Diagnostics Inc., dba ITC, dba Accumetrics recalls Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.

Recalled June 1, 2016 · FDA recall Z-1720-2016 · Accriva Diagnostics Inc.,

Hazard

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. · FDA Class II

Units

135 boxes

Sold at

U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany.

Description

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.

Manufacturer(s)

Accriva Diagnostics Inc., dba ITC, dba Accumetrics

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →