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Open, Classified

GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460

FDA Recall Z-2623-2026 · Posted 2026-06-30

Recalling FirmRemel, Inc
Recall StatusOpen, Classified
Product CodeJTY
Date Initiated2026-06-03
Product Quantity1573

Reason for Recall

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K954986GC BASE W/ 1% GCHIRemel, L.P. · 1996-02-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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