Device product
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Z-2623-2026
Product summary
- Firm
- Remel, Inc
- Event
- Event 99132
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1573
- Official record key
device-enforcement:Z-2623-2026
Official wording
Reason: Reduced or no recovery of some strains of Neisseria gonorrhoeae.
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
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
Derived failure modes
-
Unknown
Reduced or no recovery of some strains of Neisseria gonorrhoeae.