FDA recall Z-2257-2018

Product

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

Distribution

US Distribution to the state of : Kansas

Key facts

Status

Terminated

Initiation date

2017-12-21

Report date

2018-06-27

Termination date

2021-01-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Redondo Beach, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2257-2018