Recall Z-2049-2020— 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: B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.. 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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.