Z-1720-2016 Class II Terminated
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