- Recalling firm
- Biomerieux Inc
- 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.
- Affected products (lot / model / serial)
- UDI-DI 03573026637712; Lot Number 1333393504
- Units affected
- 97680 units
- Distribution pattern
- International distribution to the countries of Austria, Germany, Luxembourg.
- Firm location
- Hazelwood, MO, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3231-2026
- Recall initiated
- July 24, 2026
- FDA classification date
- September 18, 2026
- FDA report date
- September 30, 2026
- FDA event ID
- 99749
- Last updated on HTM Vibe
- October 6, 2026
