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Biomerieux Inc Recall 88242

Description: ETEST IMIPENEM RELEBACTAM. in vitro diagnostic

Biomerieux Inc Recall 88242 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2226-2021
Event ID88242
Event DescriptionETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Product TypeDevices
DistributionWorldwide 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.
Recall ReasonMajor errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
Device Classification20210818
Device Code InfoRef 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
Center Classification Date20210806
Recall Initiation Date20210624
Recalling FirmBiomerieux Inc
Initial Notification Letter
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