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

Recall number

Z-3231-2026

Recalling firm

Biomerieux Inc

Product

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

Status

Open, Classified

Initiated

2026-07-24

Posted

2026-09-18

Terminated

not on file

Reason

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.

Root cause

Packaging process control

Action

An URGENT FIELD SAFETY NOTICE notification letter was sent to customers beginning 7/24/26. Required actions Dispose of any remaining inventory VITEK 2 AST-N461 TEST KIT (Ref 424811, Lot 1333393504) that were manufactured with Poucher 8 with timestamps from 10:06:00 to 11:11:59, as identified by product labeling. Inspect each pouch in inventory and dispose of cards with "P8" and timestamps between 10:06:00 to 11:11:59 on the label. Alternatively, dispose of all cards from Lot 1333393504 remaining in inventory. In accordance with your facility s policies, you may consider performing a retrospective review of clinically significant resistant results. Among tests previously performed, identify any possible false resistant results that may have occurred, analyze the related risks, and determine appropriate actions, if applicable. Please ensure that this information is communicated to all relevant personnel within your laboratory, retain a copy in your records, and forward this information to all parties that may use this product, including those to whom you may have transferred the product. Please complete the Acknowledgement Form in Attachment A and return it to your local bioMrieux representative to confirm receipt of this notice. It is important that you return the acknowledgement form to bioMrieux even if you determine that this product correction notice does not impact your facility. As a reminder, please visit the Resource Center to confirm if a reference package insert is associated with a Field Corrective Action or Field Safety Corrective Action. https://resourcecenter.biomerieux.com/ If you require additional assistance or have any questions, please contact your local bioMrieux Customer Service representative.

Quantity

97680 units

Distribution

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

Lot, serial or model codes

UDI-DI 03573026637712; Lot Number 1333393504

510(k) numbers

not on file

PMA numbers

not on file

Product code

LON

Firm FEI

1950204

Firm city

Hazelwood

Firm state

MO

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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