Remel GC Agar Base Recall Issued for Reduced Bacterial Recovery

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Remel, Inc. is recalling GC Agar Base products after reduced or no recovery of some Neisseria gonorrhoeae strains was identified. The Class II recall covers 1,573 units distributed nationwide and internationally.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.

What Happened

Remel, Inc. initiated a voluntary recall of GC Agar Base products due to reduced or no recovery of some strains of Neisseria gonorrhoeae.

Which Products Are Affected

The recall involves GC Agar Base (150mm) 10/PK R04030 and GC Agar Base (100mm) 10/PK R01460, totaling 1,573 units. Affected lots for R01460 (UDI-DI 848838001796) are 338950, 356898, 359912, 365679, 371863, 376799, 382136, 384712, 393488, 396333, 402458. Affected lots for R04030 (UDI-DI 848838004469) are 336864, 345992, 348754, 359925, 367829, 374235, 376786, 381488, 385224, 391312, 393478. Distribution was nationwide in the US and to Canada, Singapore, and the United Kingdom. Recall number is Z-2623-2026.

What You Should Do

Consumers and laboratories should verify lot numbers against the recalled products and follow any instructions provided by the recalling firm.

Why This Matters

The recall addresses a quality issue that may affect laboratory detection of certain bacterial strains.

Source

FDA recall Z-2623-2026, Class II, ongoing, initiated June 3, 2026.

Original source: FDA Official Notice ↗

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Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Remel, Inc. is recalling GC Agar Base products after reduced or no recovery of some Neisseria gonorrhoeae strains was identified. The Class II recall covers 1,573 units distributed nationwide and internationally.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.