FDA-Device2026-04-22Class II
Yeastone Broth, 11ML, 10/BOX YY3462
Remel, Inc
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.
Affected count
2819
Manufactured in
12076 Santa Fe Trail Dr, N/A, Lenexa, KS, United States
Products
Yeastone Broth, 11ML, 10/BOX YY3462
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1806-2026Original summary
Yeastone Broth, 11ML, 10/BOX YY3462 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. UDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723 Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore. Affected quantity: 2819
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