← FDA ENFORCEMENT
Z-1806-2026Class II

Remel, Inc

Recalling firm
Remel, Inc
Product type
Device
Status
Ongoing
Report date
2026-04-22
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.
Firm state
KS
Product quantity
2819
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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.

Product description

Yeastone Broth, 11ML, 10/BOX YY3462

Code / lot info

UDI-DI 848838018817 lots 321046, 329835, 330316, 327069, 330317, 336325, 338314, 341161, 303851, 311723

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.