Immy recall (Immuno-Mycologics, Inc)
Medical deviceClass IIOngoing
Summary: Immuno-Mycologics, Inc is recalling Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis. Reason: Neutralization Buffer may contain contaminants.
What is being recalled
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
Why
Neutralization Buffer may contain contaminants
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA. (states named: Arizona, California, Connecticut, Indiana, Michigan, Missouri, Mississippi, North Carolina, South Carolina, Texas, Washington)
How to tell if yours is affected
Lot: F5061154/UDI: 00816387021091
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1984-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 26, 2026 |
| Reported | May 6, 2026 |
| Company | Immuno-Mycologics, Inc |
| Company location | Norman, OK, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 101 units |
More recalls from Immuno-Mycologics, Inc · all medical device recalls · recalls from March 2026