FDA Enforcement
Class III
Terminated
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.
Recall: Z-2257-2018
·
Reported June 27, 2018
Enforcement
- Recall Number
- Z-2257-2018
- Event ID
- 80179
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Quantimetrix Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 27, 2018
- Initiation Date
- December 21, 2017
- Classification Date
- June 20, 2018
- Termination Date
- January 27, 2021
- Address
- 2005 Manhattan Beach Blvd, N/A, Redondo Beach, CA, 90278-1205, United States
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
The kits contained an incorrect lot of Dropper Plus Level 1 vials
Code Info
Lot 44450E
Distribution
US Distribution to the state of : Kansas
Quantity
20 kits