Z-2226-2021 Class II Terminated
FDA device recall Z-2226-2021 was initiated by Biomerieux Inc on June 24, 2021 and is designated Class II. Reason for recall: Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains. The recall status is terminated (terminated February 10, 2025). Affected quantity: 1,431.
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- June 24, 2021
- Termination Date
- February 10, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,431
Product Description
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Reason for Recall
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
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.
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