Z-2226-2021Class II

ETEST IMIPENEM RELEBACTAM. in vitro diagnostic

Name: Z-2226-2021 ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Creator: Biomerieux Inc
Published: 2021-06-24
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2021-06-24 / Terminated

FDA source

Biomerieux Inc began a recall of ETEST IMIPENEM RELEBACTAM. in vitro diagnostic on 2021-06-24. FDA classified it as Class II and gives the reason as "Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2226-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-24
Posted: 2021-08-06
Terminated: 2025-02-10
Recalling firm: bioMerieux, Inc.
Product: ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Product code: JWY Manual Antimicrobial Susceptibility Test Systems
Reason for recall: Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2226-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2226-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-06

Product code JWY

K191953Class IIETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)Biomerieux S.A. / cleared 2019-08-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)