Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Remel GC Agar Base

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Remel GC Agar Basesee related information
Date Initiated by FirmJune 03, 2026
Date PostedJune 30, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2623-2026
Recall Event ID 99132
510(K)NumberK954986 
Product Classification Culture media, for isolation of pathogenic neisseria - Product Code JTY
ProductGC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Code Information 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
FEI Number 1924669
Recalling Firm/
Manufacturer		 Remel, Inc
12076 Santa Fe Trail Dr
Lenexa KS 66215-3519
For Additional Information ContactErica Knox
800-255-6730
Manufacturer Reason
for Recall		Reduced or no recovery of some strains of Neisseria gonorrhoeae.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn June 3, 2026, the firm began notifying customers via letters titled Urgent Medical Device Recall. Customers were instructed to destroy any remaining inventory of affected lots and inform the recalling firm of the amount destroyed to receive a replacement or credit. In addition, customers should notify necessary personnel. Users should review previously reported results generated using the affected lots and assess whether retesting is appropriate based on laboratory procedures.
Quantity in Commerce1573
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JTY
-
-