FDA recall, , Moderate risk
Remel GC Agar Base
GC Agar Base may have reduced or no recovery of some strains of Neisseria gonorrhoeae.
Summary by Recall Canary from the FDA notice
What happened
Remel, Inc of Lenexa, Kansas recalled GC Agar Base (150mm) 10/PK R04030 and GC Agar Base (100mm) 10/PK R01460 because of reduced or no recovery of some strains of Neisseria gonorrhoeae. The recall began June 3, 2026 and was added to the FDA's Enforcement Report on June 30, 2026. The products were distributed worldwide, including US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
- UDI-DI
- 848838001796
- 848838004469
- Lot code
- 338950
- 356898
- 359912
- 365679
- 371863
- 376799
- 382136
- 384712
- 393488
- 396333
- 402458
- 336864
- 345992
- 348754
- 359925
- 367829
- 374235
- 376786
- 381488
- 385224
- 391312
- 393478
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
- Company
- Remel, IncLenexa, Kansas
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99132
- Recall number
- Z-2623-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
