Device product
Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.
Z-1108-2021
Product summary
- Event
- Event 87151
- Status
- Terminated
- Classification
- Class II
- Quantity
- 205 total kits
- Official record key
device-enforcement:Z-1108-2021
Official wording
Reason: Intermittent potential for shorter than expected clot times.
Code information: Model Number: 5722 Lot Numbers: 1-20-5722 expiration date 90/30/2021; 3-20-5722 expiration date 11/30/2021; 4-20-5722 expiration date 12/31/2021
Distribution pattern: Worldwide distribution - U.S. Nationwide distribution and the countries of Germany, Italy, Romania, Australia, Chile.
Derived failure modes
-
Unknown
Intermittent potential for shorter than expected clot times.