Recall Z-2050-2020— Cardinal Health Inc.
Class II · Terminated
Class II FDA medical device recall by Cardinal Health Inc., initiated 2020-04-20, terminated 2020-07-23. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Cardinal Health Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-20
- Terminated
- 2020-07-23
- Firm location
- Dublin, OH, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.