FDA-Device2021-08-11Class III
Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
Stanbio Laboratory, LP
Hazard
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Sold states
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.
Affected count
7,108 products
Manufactured in
1261 N Main St, Boerne, TX, United States
Products
Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2199-2021Don't want to check this manually?
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