Z-2050-2020 Class II Terminated
FDA device recall Z-2050-2020 was initiated by Cardinal Health Inc. on April 20, 2020 and is designated Class II. 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 patie… The recall status is terminated (terminated July 23, 2020). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- April 20, 2020
- Termination Date
- July 23, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.
Distribution Pattern
US Nationwide distribution NC, KS, and AL.
Code Information
Lot KN00146