ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
FDA Recall Z-2226-2021 · Posted None
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Recalling FirmBiomerieux Inc
Recall StatusTerminated
Product CodeJWY
Date Initiated2021-06-24
Date Terminated2025-02-10
Product Quantity1,431
Reason for Recall
Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
Firm Action
The recall notification was issued to the impacted subsidiaries and distributors on 24JUN2021. The notification includes a Customer Letter to be translated into local language and sent to each impacted customer.
The customer letter will inform the customers about the MIC overestimation and false resistant results issue and will be instructed to:
- Perform a retest using an alternative method on P. aeruginosa strains for which they obtained resistant or intermediate results with ETEST IMIPENEM RELEBACTAM ref. 420925 and 420927
- Among tests previously performed, identify any possible false resistant/intermediate results that may have occurred, to analyze the related risks and to determine appropriate actions if relevant.
Root Cause
Under Investigation by firm
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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