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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 Quality Control Kits Recalled for Bacterial Contamination

Agency Publication Date: July 17, 2025
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Summary

Microbiologics Inc is recalling 21 units of KWIK-STIK and LYFO DISK quality control kits for culture media. The affected products, specifically Catalog # 0805K and 0805L, contain Staphylococcus epidermidis bacteria instead of the expected Brevundimonas diminuta. Laboratory users should stop using the affected kits and contact the manufacturer or their distributor to arrange for a return, replacement, or correction of the items.

Risk

The presence of the incorrect bacteria can cause laboratory quality control tests to fail. This may lead to inaccurate testing results and delayed medical diagnosis for patients. No injuries or incidents have been reported to date.

What You Should Do

  1. The recalled products are KWIK-STIK and LYFO DISK quality control kits (Catalog # 0805K and 0805L) sold under lot numbers 805-234-4 or 805-234-5.
  2. Stop using the recalled product immediately.
  3. Contact Microbiologics Inc or your distributor to arrange for the return, replacement, or correction of the affected kits.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this 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: Microbiologics Quality Control Kit for Culture Media
Variants: KWIK-STIK, LYFO DISK
Model / REF:
0805K
0805L
Lot Numbers:
805-234-4
805-234-5
UDI:
30845357019531
10845357019544

Catalog # 0805K and 0805L; Affected products contain Staphylococcus epidermidis instead of Brevundimonas diminuta.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97096
Status: Active
Manufacturer: Microbiologics Inc
Sold By: Microbiologics Inc
Manufactured In: United States
Units Affected: 21 total
Distributed To: Utah, Ohio

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.