Device product
HARDY DIAGNOSTICS CatScreen, 25dsk/vial
Z-0554-2022
Product summary
- Event
- Event 89151
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 units (4 packs, 25 per pack)
- Official record key
device-enforcement:Z-0554-2022
Official wording
Reason: Product stored incorrectly in temperature controlled setting instead of refrigeration.
Code information: Model Number HADZ110, all lots
Distribution pattern: US Nationwide distribution in the state of California.
Derived failure modes
-
Unknown
Product stored incorrectly in temperature controlled setting instead of refrigeration.