Device product
Hydroxybutyrate LiquiColor Tests - includes 3 bottles (1 of each size, 3mL, 8.5mL, and 50mL)
Z-0932-2022
Product summary
- Event
- Event 89857
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45 ea
- Official record key
device-enforcement:Z-0932-2022
Official wording
Reason: Product was improperly store which may cause a delay in results.
Code information: Model/Item No. S-O2440058; Lots 171793, 169614, 167181, 171713 UDI: 00657498000519
Distribution pattern: US distribution only - AL, CA, FL, GA, IL, IN, LA, MO, MS, NC, NE, NY, OH, PA, VA, and WA
Derived failure modes
-
Unknown
Product was improperly store which may cause a delay in results.