Device product
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Z-2761-2019
Product summary
- Event
- Event 83629
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21 kits
- Official record key
device-enforcement:Z-2761-2019
Official wording
Reason: Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
Code information: Lot number 2-17-5722, Exp. 2018-09-30
Distribution pattern: Distribution was made to Germany and Australia. There was no U.S. distribution.
Derived failure modes
-
Unknown
Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.