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[Recalled] VITEK¿ 2 Systems Software Version 9.01 Update Kit. — The VITEK¿ 2 Systems Software Version 9.01 software may display incorrect organ… | FDA 2018-11-13

recall fda device united-states

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

ProductVITEK¿ 2 Systems Software Version 9.01 Update Kit.
Brand / manufacturerbioMerieux, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0639-2019
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date13 November 2018
EAN / barcode03573026561260

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from bioMerieux, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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