Quick Facts at a Glance
- Recall Date
- March 26, 2026
- Hazard Level
- HIGH
- Brand
- Immuno-Mycologics
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Immuno-Mycologics
- Model numbers
- Lot: F5061154/UDI: 00816387021091
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 26, 2026
Reported by FDA DEVICE
May 6, 2026
RecallRadar source check
May 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Neutralization Buffer may contain contaminants
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Immuno-Mycologics, Inc or your healthcare provider for instructions
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Full Description
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. Classification: Class II. Quantity: 101 units. Distribution: US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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