Summary
The FDA issued a Class II for VITEK 2 AST-N447 TEST KIT Product reference 424620 by Biomerieux Inc. Reason: Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fracture.
Details
Source
Device Recall
External ID
Z-2715-2026
Action Date
2026-07-15
Status
Ongoing
Category
device
Product Description
VITEK 2 AST-N447 TEST KIT Product reference 424620
Lot/Code Info: Lot 0853293604 UDI-DI 03573026634551 Product is not registered in the US. OUS only.
Quantity Affected: 45,900 cards
Reason for Recall
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Distribution
International distribution to the countries of Belgium and the Netherlands.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-04
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 143 device recalls issued in the same week, part of 452 device-related FDA actions this month.
Biomerieux Inc has 147 FDA actions in our database, including 123 recalls and 24 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 147 FDA actions in our database, including 123 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2715-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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