FDA-Device2020-05-27Class II
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.
Cardinal Health Inc.
Hazard
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.
Sold states
US Nationwide distribution NC, KS, and AL.
Affected count
N/A
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2050-2020Don't want to check this manually?
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