Z-2049-2020 Class II Terminated
FDA device recall Z-2049-2020 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
B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.
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 193462