Remel, Inc — Class II: GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Remel, Inc. has initiated a Class II recall for specific GC Agar Base products (150mm and 100mm formats) due to reports of reduced or absent recovery of certain strains of Neisseria gonorrhoeae.
This affects Remel, Inc., clinical microbiology laboratories using these specific agar bases for Neisseria cultures, and diagnostic device quality control departments.
The failure of a selective growth medium to recover target pathogens represents a significant diagnostic risk, potentially leading to false-negative results in clinical settings. From a regulatory perspective, this suggests a failure in product performance or manufacturing quality control that warrants a formal recall and corrective action to ensure the media meets its labeled specifications for microbial recovery.
Laboratory personnel should immediately identify and sequester affected lots of GC Agar Base (R04030 and R01460). Regulatory and QA teams should evaluate previous diagnostic results obtained using these media for potential false negatives and initiate a formal CAPA to investigate the root cause of the media's failure to support N. gonorrhoeae growth.
Class II. Reason: Reduced or no recovery of some strains of Neisseria gonorrhoeae.. Product: GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460. Firm: Remel, Inc (Lenexa KS United States). Status: Ongoing.
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