VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING recall
Biomerieux Inc recalled VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING on September 30, 2026 because of 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. It was sold in International distribution to the countries of Austria, Germany, Luxembourg..
Why it was recalled
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.
What's recalled
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Quantity: 97680 units
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Biomerieux Inc, Hazelwood, MO
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- International distribution to the countries of Austria, Germany, Luxembourg.
- Status
- Ongoing
- Recall number
- Z-3231-2026
- Source
- U.S. Food and Drug Administration
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