CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report

Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled

Biomerieux is recalling Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility Testing - Automated, Reference. The recall was initiated on 24 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 03573026637712; Lot Number 1333393504

Quantity recalled97680 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3231-2026
FDA event ID: 99749
Recalling firm: Biomerieux, Hazelwood, MO
Classification: Class II
Status: Ongoing
Recall initiated: 24 Jul 2026
FDA classified: 18 Sep 2026
Reported: 30 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

24 Jul 2026	Recall initiated by company
18 Sep 2026	Classified by FDA	+56 days
30 Sep 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential risk of false resistant results. False resistant results may lead to the use of less effective antibiotic treatments or the association of multiple antibiotics having negative side effects, which could potentially impact patient s health.

Product as listed by the FDA

VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811

Where it was distributed

International distribution to the countries of Austria, Germany, Luxembourg.

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI 03573026637712; Lot Number 1333393504

Where was it sold?

International distribution to the countries of Austria, Germany, Luxembourg.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Biomerieux

All 477

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	Vitek 2 Ast-N447 Test Kit Product reference recalled by Biomerieux	Biomerieux	Other	MO
11 Feb 2026Device	CLASS II	Vitek-negative Susceptibility Cards Containing o Polymyxin recalled	Biomerieux	Sterility	Nationwide
8 Oct 2025Device	CLASS II	Vitek¿-negative AST Test Kits (Cards) recalled by bioMerieux	bioMerieux	Sterility	NC
1 May 2024Device	CLASS I	Vitek 2 - AST Test kits (in vitro diagnostic test cards recalled	Biomerieux	Other	MO
8 Mar 2023Device	CLASS II	Myla comprises Ast Filters in conjunction with Vitek MS recalled	Biomerieux	Other	Nationwide

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