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Biomerieux Inc recalls ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Recalled August 18, 2021 · FDA recall Z-2226-2021 · Biomerieux
Hazard
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains. · FDA Class II
Units
1,431
Sold at
Worldwide distribution - US Nationwide distribution including in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii. The countries of Austria, Belgium, Croatia, Czech Republic, France, Germany, Greece, Italy, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland and United Kingdom.
Description
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
Product
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Manufacturer(s)
Biomerieux Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →