Device product
Yeastone Broth, 11ML, 10/BOX YY3462
Z-1806-2026
Product summary
- Firm
- Remel, Inc
- Event
- Event 98616
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2819
- Official record key
device-enforcement:Z-1806-2026
Official wording
Reason: 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.
Code information: UDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.
Derived failure modes
-
Unknown
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.