Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point...
FDA Recall #Z-2257-2018 — Class III — December 21, 2017
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
Recalling Firm
Quantimetrix Corporation — Redondo Beach, CA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
20 kits
Distribution
US Distribution to the state of : Kansas
Code Information
Lot 44450E
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated