Consumer Alerts Tracker
openFDA Medical device

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

Reduced or no recovery of some strains of Neisseria gonorrhoeae.

Official details

Category
Medical device recall
Status
Ongoing
Classification
Class II
Company or vendor
Remel, Inc
Affected product
Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
Risk or reason
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
Remedy or action
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
Official ID
Z-2623-2026