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Recall Observatory FDA recall evidence

Device product

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

Z-2623-2026

June 03, 2026

Class II

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

    reason.no_named_rule · v1.0.0

    Reduced or no recovery of some strains of Neisseria gonorrhoeae.