FDA Devices Low Class III Terminated

Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.

Reported: August 11, 2021 Initiated: July 12, 2021 #Z-2200-2021

Product Description

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

Recalling Firm: Stanbio Laboratory, LP
Units Affected: 200 units
Distribution: 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.
Location: Boerne, TX

What product was recalled? ▼

Beta-Hydroxybutyrate Reagent A - Enzyme (unlabeled). in vitro diagnostic reagent.. Recalled by Stanbio Laboratory, LP. Units affected: 200 units.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on August 11, 2021. Severity: Low. Recall number: Z-2200-2021.