Device product
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Z-2226-2021
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
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.