Professional Urine Drug Control recalled over temperature-control failures

Recall date

April 20, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Cardinal Health Inc. recalls Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are co…

Recall number

Z-2050-2020

FDA classification

Class II

Brand / firm

Cardinal Health Inc.

Sold / distributed

US Nationwide distribution NC, KS, and AL.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.