FDA Recall 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 · Initiated December 21, 2017

Recall

Recall Number
Z-2257-2018
Event Number
80179
Firm
Quantimetrix Corporation
FEI Number
2020715
Product Code
JJW
Status
Terminated
Root Cause
Mixed-up of materials/components
Initiated
December 21, 2017
Terminated
January 27, 2021
Address
2005 Manhattan Beach Blvd, Redondo Beach, CA, 90278-1205

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

Action

Communication with their only customer for this recall was via e-mail and phone. Upon notification by the customer the following activities were initiated: All lots of the Dropper Plus product in inventory were 100% inspected. The customer was ask to return all of the kits to Quantimetrix. For further questions please call (310) 536-0006.

Distribution

US Distribution to the state of : Kansas

Quantity

20 kits