Immuno-Mycologics Immy Neutralization Buffer Recall: Contaminants Risk
Immuno-Mycologics recalls bulk neutralization buffer for clinical specimen processing due to potential contaminants. Affected units include specific lot numbers for Mycobacterium diagnosis tests.
Lower-risk recall
Neutralization Buffer may contain contaminants
Contact the company
What happened, in plain English
Immuno-Mycologics is recalling a bulk neutralization buffer used in clinical labs to process Mycobacterium tests. The buffer may contain contaminants that could affect test accuracy or safety. Read more at govinfonow.com/recall/49593-immuno-mycologics-immy-neutralization-buffer-recall-contaminants-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/49593-immuno-mycologics-immy-neutralization-buffer-recall-contaminants-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1984-2026
Cite this page
“Immuno-Mycologics Immy Neutralization Buffer Recall: Contaminants Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49593-immuno-mycologics-immy-neutralization-buffer-recall-contaminants-risk. Based on FDA recall #Z-1984-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1984-2026%22&limit=1).
Why it’s dangerous
The neutralization buffer may contain contaminants that could lead to inaccurate test results or potential safety issues during clinical specimen processing. This affects the reliability of Mycobacterium diagnosis tests.
Who’s affected
Laboratory staff and healthcare professionals using the buffer for Mycobacterium diagnosis tests. Those with the specific lot number F5061154 are most at risk.
How to tell if you have this one
Check for the product name 'Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL)' with reference number TBPN67-60. The affected lot number is F5061154.
- Brand
Immuno-Mycologics- Category
Medical device
What to do — step by step
Check Product Details
Verify the lot number on the product label; affected units have lot F5061154.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 11 states.
FDA distribution: “US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Connecticut, Indiana, Michigan, Mississippi, Missouri, North Carolina, South Carolina, Texas, Washington.
Recall timeline
FDA published this recall 41 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1984-2026 (March 26, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1984-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.