Quantimetrix Corporation recalls Dropper Plus Point-of-Care Urinalysis Dipstick Control kit The Quantimetrix Dropper Plus Point-of-Care Urinalysis Dipst…

Recall date

December 21, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2257-2018

FDA classification

Class III

Brand / firm

Quantimetrix Corporation

Sold / distributed

US Distribution to the state of : Kansas

Why it was recalled

The kits contained an incorrect lot of Dropper Plus Level 1 vials

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.