Device product
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.
Z-0594-2019
Product summary
- Event
- Event 81356
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 Kits
- Official record key
device-enforcement:Z-0594-2019
Official wording
Reason: Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
Code information: Lot Codes: 1-15-5701 Model/Catalog Number: 5701
Distribution pattern: US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England.
Derived failure modes
-
Unknown
Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected