← FDA ENFORCEMENT
Z-2623-2026Class II

Remel, Inc

Recalling firm
Remel, Inc
Product type
Device
Status
Ongoing
Report date
2026-07-08
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
Firm state
KS
Product quantity
1573
Initiated by
Voluntary: Firm initiated
Reason for recall

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

Product description

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

Code / lot info

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

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.