FDAFDA · Food and drugs·Recall number 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.
Published May 27, 2020 · Recall initiated: April 20, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Cardinal Health Inc.
- Distributor
- US Nationwide distribution NC, KS, and AL.
- Lot
- Lot KN00146
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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