FDA-Device2018-06-27Class III
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.
Quantimetrix Corporation
Hazard
The kits contained an incorrect lot of Dropper Plus Level 1 vials
Sold states
US Distribution to the state of : Kansas
Affected count
20 kits
Manufactured in
2005 Manhattan Beach Blvd, N/A, Redondo Beach, CA, United States
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, 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2257-2018Don't want to check this manually?
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