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Recall Observatory FDA recall evidence

Device product

ETEST IMIPENEM RELEBACTAM. in vitro diagnostic

Z-2226-2021

June 24, 2021

Class II

Product summary

Firm
Biomerieux Inc
Event
Event 88242
Status
Terminated
Classification
Class II
Quantity
1,431
Official record key
device-enforcement:Z-2226-2021

Official wording

Reason: Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.

Code information: Ref 420927 (US Product) Lot numbers 1007888860, 1008598340, 1008701580, 1007607290, 1007888870, 1008390030, 1008598350 and 1008701590 and Ref 420925 (not distributed in US):Lot Codes: 1007888860, 100859840 and 1008701580

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.