FDA recall Z-2049-2020

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 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

US Nationwide distribution NC, KS, and AL.

Key facts

Status

Terminated

Initiation date

2020-04-20

Report date

2020-05-27

Termination date

2020-07-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2049-2020