- Recalling firm
- Remel, Inc
- Reason for recall
- Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
- Affected products (lot / model / serial)
- UDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723
- Units affected
- 2819
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.
- Firm location
- Lenexa, KS, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1806-2026
- Recall initiated
- March 24, 2026
- FDA classification date
- April 10, 2026
- FDA report date
- April 22, 2026
- FDA event ID
- 98616
- Last updated on HTM Vibe
- July 24, 2026