FDA recall Z-2050-2020

Cardinal Health Inc. · Class II · device

Product

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.

Reason for recall

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.

Distribution

US Nationwide distribution NC, KS, and AL.

Key facts

Status
Terminated
Initiation date
2020-04-20
Report date
2020-05-27
Termination date
2020-07-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2050-2020