FDA-Device2025-12-31Class IIPROCESSING DEFECT
Microbiologics KWIK-STIK Campylobacter jejuni test kit recalled for potential recovery failure
What this means
Microbiologics Inc. has recalled specific lots of KWIK-STIK 2-Pack test kits used to detect Campylobacter jejuni bacteria. The affected units may fail to correctly recover the target microorganism, which could lead to false negative test results in laboratory testing.
- Check if your KWIK-STIK kit matches lot numbers 325-120-3, 325-120-7, 325-119-1, or 325-119-5
- Stop using affected kits immediately
- Contact Microbiologics Inc. for replacement or instructions on next steps
- Review any recent test results using these kits for accuracy
The agency's original wording
Hazard
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Intended for
All ages
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide.
Affected count
86 units (127 additional units 12/22/25)
Manufactured in
200 Cooper Ave N, N/A, Saint Cloud, MN, United States
Products
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0984-2026Want us to check the next one for you?
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