B-Hydroxybutyrate LiquiColor recalled over temperature-control failures
- Recall date
- April 20, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Cardinal Health Inc. recalls B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination o…
- Recall number
- Z-2049-2020
- FDA classification
- Class II
- Brand / firm
- Cardinal Health Inc.
- Sold / distributed
- US Nationwide distribution NC, KS, and AL.
Why it was 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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.
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