Stanbio Laboratory, LP recalls Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.

Recall date

July 12, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2202-2021

FDA classification

Class III

Brand / firm

Stanbio Laboratory, LP

Sold / distributed

Worldwide distribution - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, TN, TX, VA, VT, WA, WI, and WV. The countries of Australia, Canada, Chile, Federa…

Why it was recalled

Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Cardinal Health Beta-Hydroxybutyrate . in vitro diagnostic reagent.