FDA recall Z-1806-2026

Remel, Inc · Class II · device

Product

Yeastone Broth, 11ML, 10/BOX YY3462

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.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.

Key facts

Status
Ongoing
Initiation date
2026-03-24
Report date
2026-04-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lenexa, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1806-2026