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

Recall Z-2050-2020 — Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.

U.S. FDA — Device Enforcement · United States · 2020-04-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2050-2020
Date of alert
2020-04-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cardinal Health Inc.
Product category
device
Product type
Devices
Reported risk: Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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