RecallReported September 30, 2026
Class II recall by Biomerieux Inc
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
FDA's enforcement report of September 30, 2026 lists a Class II recall by Biomerieux Inc of Hazelwood, MO. Product: VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811. Status: Ongoing.
On the record
- Recalling firm
- Biomerieux Inc
- Location
- Hazelwood, MO
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-3231-2026
- Product type
- Devices
- Recall initiated
- 2026-07-24
- Reported by FDA
- 2026-09-30
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
More
Watch Biomerieux Inc
A free account shows the last 7 days of every record. Pro adds a watchlist: one email when FDA acts on a company you name.
From FDA enforcement reports. The record may have changed since it was read.
Approve Suite is not affiliated with FDA, or with Biomerieux Inc.
See something wrong on this page? Write to info@approvesuite.com and we will check it against the source. How corrections work.