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Recall Observatory FDA recall evidence

Device 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

Z-1984-2026

March 26, 2026

Class II

Product summary

Firm
Immuno-Mycologics, Inc
Event
Event 98702
Status
Ongoing
Classification
Class II
Quantity
101 units
Official record key
device-enforcement:Z-1984-2026

Official wording

Reason: Neutralization Buffer may contain contaminants

Code information: Lot: F5061154/UDI: 00816387021091

Distribution pattern: US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Neutralization Buffer may contain contaminants