GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
FDA device recall Z-2623-2026 · posted 2026-06-30 · Open, Classified
Recall details
- Recalling firm
- Remel, Inc
- Reason for recall
- Reduced or no recovery of some strains of Neisseria gonorrhoeae.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- JTY
- Quantity affected
- 1573
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
- Date initiated
- 2026-06-03
- Date posted
- 2026-06-30
- Location
- Lenexa, KS
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GC BASE W/ 1% GCHI (K954986) | Remel, L.P. | 1996-02-16 |