Device product
Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipstick Control is intended as a control for urinalysis reagent strips, microalbumin, and creatinine by the listed test methods, and as a control for confirmatory tests such as K-CHECK and Ictotest reagent tablets, and for hCG methods.
Z-2257-2018
Product summary
- Event
- Event 80179
- Status
- Terminated
- Classification
- Class III
- Quantity
- 20 kits
- Official record key
device-enforcement:Z-2257-2018
Official wording
Reason: The kits contained an incorrect lot of Dropper Plus Level 1 vials
Code information: Lot 44450E
Distribution pattern: US Distribution to the state of : Kansas
Derived failure modes
-
Unknown
The kits contained an incorrect lot of Dropper Plus Level 1 vials