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Remel, Inc: Yeastone Broth, 11ML, 10/BOX YY3462

Medical DevicesSource: FDA (device) · Date: 2026-04-22

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Remel, Inc
Product
Yeastone Broth, 11ML, 10/BOX YY3462
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.
Recall initiated
2026-03-24
Code info
UDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723
Product quantity
2819
Voluntary mandated
Voluntary: Firm initiated
City
Lenexa
State
KS
Country
United States
Event id
98616
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