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
Z-0561-2019
Product summary
- Event
- Event 81378
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 kits
- Official record key
device-enforcement:Z-0561-2019
Official wording
Reason: Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.
Code information: Lot Codes: 1-16-5701 Model/Catalog Number: 5701
Distribution pattern: US: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England
Derived failure modes
-
Unknown
Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.