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Immuno-Mycologics, Inc: Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium sp

Medical DevicesSource: FDA (device) · Date: 2026-05-06

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Immuno-Mycologics, Inc
Product
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 / hazard
Neutralization Buffer may contain contaminants
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.
Recall initiated
2026-03-26
Code info
Lot: F5061154/UDI: 00816387021091
Product quantity
101 units
Voluntary mandated
Voluntary: Firm initiated
City
Norman
State
OK
Country
United States
Event id
98702
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