FDA Device

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.

Hazard

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

What You Should Do

Remedy

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.

Products

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
Brand
Quantimetrix Corporation
UPC
Lot 44450E

Units Affected

20 kits