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Lower risk Medical device recall · FDA · Published June 24, 2021

Biomerieux ETEST IMIPENEM RELEBACTAM Recall: False Pseudomonas Results

Biomerieux recalls ETEST IMIPENEM RELEBACTAM in vitro diagnostics due to false resistant results for Pseudomonas aeruginosa. Affected lots include 1007888860, 1008598340, and others. Stop using if you have these lots.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2226-2021Medical deviceBiomerieux ›
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Contact the company

Recalling firmBiomerieux Inc595 Anglum Rd · Hazelwood, MO 63042-2320
✎ GovInfoNow plain-language explainer

Biomerieux is recalling ETEST IMIPENEM RELEBACTAM diagnostic tests because they sometimes show false 'resistant' results for Pseudomonas aeruginosa bacteria. This could lead to incorrect antibiotic treatment decisions. The recall affects specific lot numbers sold in the US. Read more at govinfonow.com/recall/62307-biomerieux-etest-imipenem-relebactam-recall-false-pseudomonas-results.

Source Summary by GovInfoNow · govinfonow.com/recall/62307-biomerieux-etest-imipenem-relebactam-recall-false-pseudomonas-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2226-2021

Cite this page

“Biomerieux ETEST IMIPENEM RELEBACTAM Recall: False Pseudomonas Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62307-biomerieux-etest-imipenem-relebactam-recall-false-pseudomonas-results. Based on FDA recall #Z-2226-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2226-2021%22&limit=1).

The FDA announced on June 24, 2021, that Biomerieux Inc is recalling ETEST IMIPENEM RELEBACTAM in vitro diagnostic tests due to major errors that may show resistant results instead of susceptible ones for Pseudomonas aeruginosa strains. The recall involves 1,431 units distributed worldwide and in the United States.

How to tell if you have it

  • Brand: Biomerieux
  • Product: ETEST IMIPENEM RELEBACTAM in vitro diagnostic
  • Reference 420927 (US Product) Lot numbers: 1007888860, 1008598340, 1008701580, 1007607290, 1007888870, 1008390030, 1008598350 and 1008701590
  • Reference 420925 (not distributed in US) Lot Codes: 1007888860, 100859840 and 1008701580

The hazard

The recall was issued because major errors were observed with Pseudomonas aeruginosa strains, specifically resistant results appearing instead of susceptible ones. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Biomerieux Inc has 36 other recalls on record since July 12, 2017. Other recent recalls of similar products include Biomerieux VITEK 2 AST-N461 Test Kit Recall (July 24, 2026), Biomerieux VITEK 2 AST-N447 Kit Recall (June 4, 2026), and Biomerieux VITEK 2 Gram-negative Susceptibility Cards May Give False Antibiotic Results (Jan. 5, 2026). Other recent recalls of similar products include Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025), Remel Yeastone Broth Recall (March 24, 2026), and Vivoo Vaginal pH Test Recall (Nov. 22, 2025).

How to tell if you have this one

Check the lot number on the ETEST IMIPENEM RELEBACTAM packaging. Affected lots include 1007888860, 1008598340, 1008701580, and others listed in the recall notice.

  • Brand
    Biomerieux
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Lot Number

    Look for the lot number on the ETEST IMIPENEM RELEBACTAM packaging to see if it matches the affected lots listed in the recall.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 35 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 3.6 years after the firm started it.

1. Firm started the recall: Jun 24, 202112. FDA classified it Class II: Aug 6, 202123. Published in FDA’s Enforcement Report: Aug 18, 202134. FDA terminated the recall: Feb 10, 2025420212025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have an affected lot?

Contact Biomerieux directly to confirm if your lot is affected and follow their instructions.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2226-2021 (June 24, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2226-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA