Medical device recalls Moderate risk

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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