Recall of Immy Myco DDR Trident Neutralization Buffer Due to Contaminants

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.

Immuno-Mycologics, Inc. is voluntarily recalling 101 units of Immy Myco DDR Trident Bulk Neutralization Buffer because it may contain contaminants, affecting products used for processing clinical specimens.

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

This notice was issued by FDA on May 14, 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, cpsc, Devices.

Recall of Immy Myco DDR Trident Neutralization Buffer

What Happened

Immuno-Mycologics, Inc. is recalling the product because the Neutralization Buffer may contain contaminants.

Which Products Are Affected

The affected product is Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60, used for processing of clinical specimens for Mycobacterium spp. diagnosis. It includes Lot: F5061154 and UDI: 00816387021091. A total of 101 units are affected, with distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, and CA, as part of US nationwide distribution. The official recall number is Z-1984-2026.

What You Should Do

Consumers should contact Immuno-Mycologics, Inc. at their address, 2701 Corporate Centre Dr, Norman, OK 73069-2901, for instructions on returns or refunds related to this recall.

Why This Matters

This recall involves a medical device that could impact the accuracy of clinical specimen processing, potentially affecting diagnostic outcomes for patients.

Source

FDA Recall Number: Z-1984-2026. For more information, refer to the FDA website.

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?
Immuno-Mycologics, Inc. is voluntarily recalling 101 units of Immy Myco DDR Trident Bulk Neutralization Buffer because it may contain contaminants, affecting products used for processing clinical specimens.
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.