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Remel, Inc: GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460

Medical DevicesSource: FDA (device) · Date: 2026-07-08

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Remel, Inc
Product
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Reason / hazard
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
Recall initiated
2026-06-03
Code 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
Product quantity
1573
Voluntary mandated
Voluntary: Firm initiated
City
Lenexa
State
KS
Country
United States
Event id
99132
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