Z-2623-2026 Class II Ongoing
FDA device recall Z-2623-2026 was initiated by Remel, Inc on June 3, 2026 and is designated Class II. Reason for recall: Reduced or no recovery of some strains of Neisseria gonorrhoeae. The recall status is ongoing. Affected quantity: 1573.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2026
- Initiation Date
- June 3, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1573
Product Description
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Reason for Recall
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
Code Information
R01460 - GC Agar Base (100mm) 10/PK UDI-DI 848838001796 Lots 338950 356898 359912 365679 371863 376799 382136 384712 393488 396333 402458; R04030 - GC Agar Base (150mm) 10/PK UDI-DI 848838004469 Lots 336864 345992 348754 359925 367829 374235 376786 381488 385224 391312 393478