FDA DeviceClass IINotable

FDA Recall: Yeastone Broth, 11ML, 10/BOX YY3462

Date: 2026-04-22
Brand: Remel, Inc
Category: Medical Device
FDA Class: Class II

Description

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.

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.

Remedy

2819

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