Reported Jun 27, 2018 · Terminated

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

Quantimetrix Corporation

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Quantimetrix Corporation · 2005 Manhattan Beach Blvd · Redondo Beach, CA · 90278-1205

Is this the product you have?

  • 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.
Lot codes and dates
  • Lot 44450E
Amount recalled
20 kits

Where it was sold

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 27, 2021 · Data as of Sep 19, 6:47 PM UTC

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