Accriva Diagnostics Inc., dba ITC, dba Accumetrics: Medical Device Recall in 2016 - (Recall #: Z-1720-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 22, 2016

Date Posted: June 1, 2016

Recall Number: Z-1720-2016

Event ID: 73949

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.

Status: Terminated

Product Quantity: 135 boxes

Code Information:

Lot #B6JCA012

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated