FDA Medical devices recall ·
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING -… recall
- Recall number
- Z-3231-2026
- Date
- (initiated July 24, 2026)
- Company / brand
- Biomerieux Inc
595 Anglum Rd, Hazelwood, MO, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 97680 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Why was it 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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI 03573026637712; Lot Number 1333393504
Distribution
International distribution to the countries of Austria, Germany, Luxembourg.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3231-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.