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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Microbiologics KWIK-STIK and LYFO DISK Recalled for Testing Failure

Agency Publication Date: December 22, 2025
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Summary

Microbiologics Inc. is recalling KWIK-STIK (2-Pack and 6-Pack) and LYFO DISK products containing the Campylobacter jejuni microorganism. The recall involves 105 units (with 152 additional units identified later) that may fail to recover or grow the target bacteria during laboratory testing. This issue was identified during internal quality control monitoring and affects the accuracy of the product when used as a control organism.

Risk

If the microorganism fails to grow correctly, laboratory quality control tests may produce inaccurate results. This could lead to validation failures or errors in diagnostic processes that rely on these control organisms to ensure testing accuracy.

What You Should Do

  1. This recall affects Microbiologics KWIK-STIK (2-Pack and 6-Pack) and LYFO DISK products containing the microorganism Campylobacter jejuni subsp. jejuni (derived from ATCC 29428).
  2. Identify your product by checking the Catalog Numbers 0325P, 0325K, or 0325L and verifying the lot numbers or UDI-DI codes on the packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately.
  4. Contact Microbiologics Inc. or your laboratory distributor to arrange for a return, replacement, or correction of the affected units.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni (derived from ATCC 29428)
Variants: 2-Pack
Model / REF:
0325P
Lot Numbers:
325-120-3
325-120-7
325-119-1
325-119-5
UDI:
20845357006459

Quantity: 86 units (127 additional units 12/22/25)

Product: KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni (derived from ATCC 29428)
Variants: 6-Pack
Model / REF:
0325K
Lot Numbers:
325-120-1
325-120-4
325-120-6
325-119-2
UDI:
30845357006463

Quantity: 18 units (9 additional units 12/22/25)

Product: LYFO DISK, Campylobacter jejuni subsp. jejuni (derived from ATCC 29428)
Variants: Microorganism disk
Model / REF:
0325L
Lot Numbers:
325-120-5
325-119-3
325-119-6
UDI:
10845357006476

Quantity: 1 unit (16 additional units added 12/22/25)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98079
Status: Active
Manufacturer: Microbiologics Inc
Sold By: Laboratory distributors; Microbiologics Inc
Manufactured In: United States
Units Affected: 3 products (86 units (127 additional units 12/22/25); 18 units (9 additional units 12/22/25); 1 unit (16 additional units added 12/22/25))
Distributed To: Nationwide
Agency Last Updated: January 2, 2026

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.