Z-3231-2026 Class II Ongoing
FDA device recall Z-3231-2026 was initiated by Biomerieux Inc on Jul 24, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 97680 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 30, 2026
- Initiation Date
- Jul 24, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 97680 units
Product Description
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
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 Pattern
International distribution to the countries of Austria, Germany, Luxembourg.
Code Information
UDI-DI 03573026637712; Lot Number 1333393504
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3231-2026
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026