Remel, Inc recalls GC Agar Base (150mm) 10/PK R04030

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

On June 3, 2026, the firm began notifying customers via letters titled Urgent Medical Device Recall. Customers were instructed to destroy any remaining inventory of affected lots and inform the recalling firm of the amount destroyed to receive a replacement or credit. In addition, customers should notify necessary personnel. Users should review previously reported results generated using the affected lots and assess whether retesting is appropriate based on laboratory procedures.

• FDA enforcement recordOfficial FDA database entry for Z-2623-2026
• FDA 510(k) clearance · K954986The device's official FDA premarket clearance record
• FDA device classification · JTYOfficial FDA classification for this device type
• CFR regulation · 21 CFR 866.2410The 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.