FDA-Device2026-04-22Class IIPROCESSING DEFECT
Remel Yeastone Broth recalled for incorrect antifungal susceptibility test results
OTHERNationwide distribution
Check Remel Yeastone Broth test results
Remel's Yeastone Broth (11ML, 10/BOX, model YY3462) may give wrong results when labs use it to test how fungi respond to antifungal medicines. If a lab doesn't catch the bad result during its own quality checks, doctors might delay treatment or switch to a different antifungal drug unnecessarily.
- If your lab received Yeastone Broth from affected lots (321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723), verify recent antifungal susceptibility test results
- Contact Remel or your supplier for instructions on the affected product
- Review any patient reports or treatment changes related to antifungal testing from these lots
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-1806-2026Don't want to check this manually?
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