Remel, Inc — Class II: Yeastone Broth, 11ML, 10/BOX YY3462
Remel, Inc has initiated a Class II recall for Yeastone Broth (Catalog YY3462) due to reports of incorrect Antimicrobial Susceptibility Testing (AST) results during quality control procedures.
This affects Remel, Inc, clinical microbiology laboratories utilizing Yeastone Broth for antifungal susceptibility testing, and healthcare providers relying on these diagnostic results.
Failure of the broth to provide accurate Quality Control results suggests a potential risk to the reliability of clinical diagnostic data. If QC failures are overlooked, there is a risk of delayed treatment or inappropriate selection of antifungal agents, potentially impacting patient outcomes in a clinical setting.
Laboratory managers should immediately sequester the affected lot YY3462 and review QC logs for discrepancies in AST results. Quality Assurance teams should evaluate if any clinical results were released despite failed QC and initiate necessary communication with clinical staff.
Class II. Reason: 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: Yeastone Broth, 11ML, 10/BOX YY3462. Firm: Remel, Inc (Lenexa KS United States). Status: Ongoing.
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