Home / Recalls / Medical Devices
Stanbio Laboratory, LP recalls Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
Recalled August 11, 2021 · FDA recall Z-2200-2021 · Stanbio Laboratory
Hazard
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values. · FDA Class III
Units
200 units
Sold at
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, Federal Republic of Germany, Hong Kong, Singapore, Taiwan, Thailand, United Kingdom, and Viet Nam.
Description
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Product
Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.
Manufacturer(s)
Stanbio Laboratory, LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →