Reported Aug 18, 2021 · Terminated

ETEST IMIPENEM RELEBACTAM. in vitro diagnostic

Biomerieux Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biomerieux Inc · 595 Anglum Rd · Hazelwood, MO · 63042-2320

Is this the product you have?

  • ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Lot codes and dates

3 of 3 products

Products covered by this recall
Model / numberProduct as published
420927(US Product)
Lot numbers 1007888860, 1008598340, 1008701580, 1007607290, 1007888870, 1008390030, 1008598350 and 1008701590 and
420925(not distributed in US):Lot Codes: 1007888860, 100859840 and 1008701580
Amount recalled
1,431

Where it was sold

Why it was recalled

Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeruginosa strains.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 10, 2025 · Data as of Sep 19, 7:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.