Recall Z-2623-2026 ยท JTY Culture Media, For Isolation Of Pathogenic Neisseria
Remel, Inc
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
| Date | Jun 30, 2026 (initiated Jun 3, 2026) |
| Status | Open, Classified |
| Reason | Reduced or no recovery of some strains of Neisseria gonorrhoeae. |
| Root cause | Under Investigation by 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. |
| Quantity | 1573 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954986 | GC BASE W/ 1% GCHI Remel, L.P., Feb 16, 1996 |