Moderate riskFDA DeviceClass II

Remel Yeastone Broth recalled for incorrect antifungal susceptibility 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.

From the FDA notice · Read the official notice ↗ · All Remel recalls

What to do

  1. 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
  2. Contact Remel or your supplier for instructions on the affected product
  3. Review any patient reports or treatment changes related to antifungal testing from these lots

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Yeastone Broth, 11ML, 10/BOX YY3462
Sold in
Nationwide
Made for
All ages (0 months and older)

Details

Units affected
2819
Illnesses reported
None reported
Manufactured in
12076 Santa Fe Trail Dr, N/A, Lenexa, KS, United States
Classification
Class II
Recall number
Z-1806-2026

In the FDA's words

Description
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
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.

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