Reported Dec 26, 2018 · Terminated

VITEK¿ 2 Systems Software Version 9.01 Update Kit.

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. · 100 Rodolphe St · Durham, NC · 27712-9402

Is this the product you have?

  • VITEK¿ 2 Systems Software Version 9.01 Update Kit.
Lot codes and dates
  • Product DescriptionKIT UPDT VTK2 9.01 EN
  • UDI03573026561260
Amount recalled
five (5) VITEK¿ 2 Systems Software version 9.01

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organism identification information as well as the associated Antimicrobial Susceptibility Testing (AST) results when using the VITEK¿ 2 FLEXPREP" feature.

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 Jul 7, 2021 · Data as of Sep 19, 5:34 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.