FDA Medical Device Recalls (openFDA)
Biomerieux Inc: ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
- Recall number
- Z-2226-2021
- Recalling firm
- Biomerieux Inc
- Product
- ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
- Status
- Terminated
- Initiated
- 2021-06-24
- Posted
- not on file
- Terminated
- 2025-02-10
- Reason
- Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
- Root cause
- Under Investigation by 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.
- Quantity
- 1,431
- Distribution
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K191953"]
- PMA numbers
- not on file
- Product code
- JWY
- Firm FEI
- 1950204
- Firm city
- Hazelwood
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28