The Recall Desk
HighFDA (Devices)·Z-2623-2026·Announced 2026-07-08

GC Agar Base Culture Media Reduced Recovery of Neisseria gonorrhoeae

Remel, Inc is recalling GC Agar Base culture media because some strains of Neisseria gonorrhoeae may not be recovered or may show reduced recovery on the product.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall. The hazard involves failure of a diagnostic culture medium to reliably recover a pathogenic bacterium (Neisseria gonorrhoeae), which creates a risk of false-negative test results and potential for patient harm through delayed or missed diagnosis, even though no illnesses or misdiagnoses have been reported.

Plain-English summary

Remel, Inc is recalling GC Agar Base (150mm) 10/PK model R04030 and GC Agar Base (100mm) 10/PK model R01460 culture media due to reduced or no recovery of some strains of Neisseria gonorrhoeae. GC Agar Base is a laboratory culture medium used to grow and identify bacteria for diagnostic purposes.

Approximately 1573 units have been distributed worldwide, including to the United States, Canada, Singapore, and the United Kingdom. Specific lot numbers for both products are identified in the recall notice.

If you have received affected product, contact Remel, Inc or the FDA for instructions on proper handling and return of the recalled units. Laboratory personnel should not use the recalled lots for clinical testing.

The recalled product

Product
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Manufacturer
Remel, Inc
Category
Medical Device — Diagnostic Culture Media
Hazard
  • diagnostic-failure
  • reduced-recovery

Distribution

Distributed nationwide across the United States.

Related recalls

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