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Recall Observatory FDA recall evidence

Device product

KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P

Z-0984-2026

December 02, 2025

Class II

Product summary

Firm
Microbiologics Inc
Event
Event 98079
Status
Ongoing
Classification
Class II
Quantity
86 units (127 additional units 12/22/25)
Official record key
device-enforcement:Z-0984-2026

Official wording

Reason: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Code information: UDI-DI: 20845357006459; Lot Numbers: 325-120-3, 325-120-7, Additional Lots added 12/22/25: 325-119-1, 325-119-5

Distribution pattern: Worldwide - US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.