FDA recall, , Moderate risk
Immuno-Mycologics Myco DDR Trident Neutralization Buffer B
Neutralization Buffer may contain contaminants.
Summary by Recall Canary from the FDA notice
What happened
Immuno-Mycologics, Inc, of Norman, Oklahoma, recalled Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60, because the Neutralization Buffer may contain contaminants. The product is used for processing of clinical specimens for Mycobacterium spp. diagnosis. The company began the recall on March 26, 2026, and it was added to the FDA's Enforcement Report on April 29, 2026, affecting 101 units.
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?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
- UDI-DI
- 00816387021091
- Lot code
- F5061154
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Arizona, Mississippi, South Carolina, Connecticut, North Carolina, Texas, Indiana, Washington, Missouri, Michigan, California.
- Company
- Immuno-Mycologics, IncNorman, Oklahoma
- Hazard
- Contamination
- 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
- 98702
- Recall number
- Z-1984-2026
- Quantity recalled
- 101 units
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
