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

Recall date

April 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1720-2016

FDA classification

Class II

Brand / firm

Accriva Diagnostics Inc., dba ITC, dba Accumetrics

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.