FDA recall Z-2199-2021

Product

Beta-Hydroxybutyrate LiquiColor. in vitro diagnostic reagent.

Reason for recall

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

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.

Key facts

Status

Terminated

Initiation date

2021-07-12

Report date

2021-08-11

Termination date

2022-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Boerne, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2199-2021