Device product
LYFO Disk
Z-0788-2022
Product summary
- Event
- Event 89513
- Status
- Completed
- Classification
- Class III
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0788-2022
Official wording
Reason: LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.
Code information: Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)
Distribution pattern: Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.
Derived failure modes
-
Labeling or packaging
labeling error