Device product
Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512
Z-1384-2022
Product summary
- Event
- Event 90435
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 63 kits
- Official record key
device-enforcement:Z-1384-2022
Official wording
Reason: Label provided for substrate vail contained incorrect expiration date.
Code information: Kit Model Number: K589911-2 UDI-DI Code for Kit: 0 5700571 11286 1 Lot Numbers: 06586309; 06646626; Vial Material Number: K859911-21512 Lot Number: 06646739 Lot Number: 06586327
Distribution pattern: U.S. Nationwide distribution in the states of NY and VA.
Derived failure modes
-
Unknown
Label provided for substrate vail contained incorrect expiration date.