VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Summary
The FDA issued a Class II for VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Ref by Biomerieux Inc. 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 ti.
Details
Source
Device Recall
External ID
Z-3231-2026
Action Date
2026-09-30
Status
Ongoing
Category
device
Product Description
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Lot/Code Info: UDI-DI 03573026637712; Lot Number 1333393504
Quantity Affected: 97680 units
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.
Distribution
International distribution to the countries of Austria, Germany, Luxembourg.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-24
Company
Hazelwood, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 196 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Biomerieux Inc has 145 FDA actions in our database, including 123 recalls and 22 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Biomerieux Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Biomerieux Inc have FDA actions?
Biomerieux Inc has 145 FDA actions in our database, including 123 recalls and 22 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3231-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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