FDA-Device2021-08-18Class II
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Biomerieux Inc
Hazard
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
Sold states
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.
Affected count
1,431
Manufactured in
595 Anglum Rd, N/A, Hazelwood, MO, United States
Products
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2226-2021Don't want to check this manually?
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