Z-2257-2018 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 27, 2018
- Initiation Date
- December 21, 2017
- Termination Date
- January 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 kits
Product Description
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.
Reason for Recall
The kits contained an incorrect lot of Dropper Plus Level 1 vials
Distribution Pattern
US Distribution to the state of : Kansas
Code Information
Lot 44450E