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.
Reported: May 27, 2020 Initiated: April 20, 2020 #Z-2050-2020
Product Description
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.
Details
- Recalling Firm
- Cardinal Health Inc.
- Units Affected
- N/A
- Distribution
- US Nationwide distribution NC, KS, and AL.
- Location
- Dublin, OH
Frequently Asked Questions
What product 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.. Recalled by Cardinal Health Inc.. Units affected: N/A.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 27, 2020. Severity: Moderate. Recall number: Z-2050-2020.
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