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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Immy Neutralization Buffer B Recalled for Potential Contamination

Agency Publication Date: April 29, 2026
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Summary

Immuno-Mycologics, Inc. is recalling 101 units of its Immy Myco DDR Trident Neutralization Buffer B used for laboratory diagnosis of Mycobacterium species. The recall was initiated because the buffer may contain contaminants that could compromise testing results. This diagnostic laboratory product was distributed nationwide to specific states including California, Texas, and Washington between March and May 2026.

Risk

The presence of contaminants in the neutralization buffer can lead to inaccurate laboratory test results, potentially causing incorrect diagnoses or delays in treatment for Mycobacterium infections.

What You Should Do

  1. Identify if you have the affected product by checking the label for Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL) with reference number TBPN67-60.
  2. Check the packaging for Lot F5061154 and UDI code 00816387021091.
  3. Stop using the recalled product immediately.
  4. Contact Immuno-Mycologics, Inc. or your distributor to arrange for the return, replacement, or correction of the affected buffer lots.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL)
Model / REF:
TBPN67-60
Lot Numbers:
F5061154
UDI:
00816387021091

For processing of clinical specimens for Mycobacterium spp. diagnosis

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98702
Status: Active
Manufacturer: Immuno-Mycologics, Inc
Sold By: Clinical laboratories; Medical distributors
Manufactured In: United States
Units Affected: 101
Distributed To: Arizona, Mississippi, South Carolina, Connecticut, North Carolina, Texas, Indiana, Washington, Missouri, Michigan, California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.