Remel, Inc recalls Yeastone Broth

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.

Firm began notifying consignees on March 24, 2026 via letters titled "Urgent: Medical Device Recall." Customers were informed that the affected products may report incorrect AST results during quality control. Customers were asked to notify any personnel who need to be aware of the issue. Laboratory professionals are advised to review previously reported susceptibility results generated using affected lots and assess whether retesting is appropriate. Remaining inventory of affected lots must be destroyed; these lots should not be used for any clinical laboratory testing. The firm is investigating the root cause and will implement corrective and preventive actions to prevent future recurrence.

• FDA enforcement recordOfficial FDA database entry for Z-1806-2026
• FDA 510(k) clearance · K090968The device's official FDA premarket clearance record
• FDA device classification · NGZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.1640The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Remel, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.