Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2257-2018 — 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-CHE

U.S. FDA — Device Enforcement · United States · 2017-12-21 · Class III

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2257-2018
Date of alert: 2017-12-21
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Quantimetrix Corporation
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Related