Z-1720-2016 Class II Terminated
FDA device recall Z-1720-2016 was initiated by Accriva Diagnostics Inc., dba ITC, dba Accumetrics on April 22, 2016 and is designated Class II. 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. The recall status is terminated (terminated December 14, 2016). Affected quantity: 135 boxes.
Recall Details
- Product Type
- Devices
- Report Date
- June 1, 2016
- Initiation Date
- April 22, 2016
- Termination Date
- December 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 135 boxes
Product Description
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
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.
Distribution Pattern
U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany.
Code Information
Lot #B6JCA012