Remel, Inc: GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Read the official notice at FDA (device) →
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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