Z-1806-2026 Class II Ongoing
FDA device recall Z-1806-2026 was initiated by Remel, Inc on March 24, 2026 and is designated Class II. 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 Contr… The recall status is ongoing. Affected quantity: 2819.
Recall Details
- Product Type
- Devices
- Report Date
- April 22, 2026
- Initiation Date
- March 24, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2819
Product Description
Yeastone Broth, 11ML, 10/BOX YY3462
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.
Code Information
UDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723