FDA-Device2021-08-11Class III
Synchron CX/DX/LX Beta-Hydroxybutyrate . 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
100 units
Manufactured in
1261 N Main St, Boerne, TX, United States
Products
Synchron CX/DX/LX Beta-Hydroxybutyrate . in vitro diagnostic reagent.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2201-2021Don't want to check this manually?
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