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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 Inc: Laboratory Pellets Recalled for Aspergillus flavus Contamination

Agency Publication Date: November 15, 2023
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Summary

Microbiologics Inc. is recalling KWIKSTIK and LYFO-DISK laboratory pellets used for scientific testing after a complaint investigation revealed the products were contaminated with Aspergillus flavus. Approximately 16 units are affected by this recall, which includes products shipped to laboratory facilities worldwide. Consumers should identify whether they have the affected lot number 794-142 and follow specific handling instructions to prevent exposure to the contaminant.

Risk

The product is contaminated with Aspergillus flavus, a mold that can produce aflatoxins and cause infections or allergic reactions in humans. In a laboratory setting, this contamination can also lead to inaccurate test results or cross-contamination of other research materials.

What You Should Do

  1. Check your inventory for KWIKSTIK P. venetum (2-pack or 6-pack) with catalog numbers 0794P or 0794K, and LYFO-DISK P. venetum with catalog number 0794L.
  2. Verify the lot numbers: for KWIKSTIK, look for lot numbers 794-142-2, 794-142-4, or 794-142-3; for LYFO-DISK, look for lot number 794-142-1.
  3. Identify the product using the UDI/DI codes: 20845357019169, 30845357019173, or 10845357019186.
  4. Stop using any affected laboratory pellets immediately and secure them to prevent accidental use or exposure.
  5. Contact Microbiologics Inc. at their Saint Cloud, Minnesota headquarters or your healthcare provider for specific instructions regarding the disposal or return of these contaminated medical devices.
  6. For additional information or to report concerns, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: KWIKSTIK, P. venetum (2-pack)
Model / REF:
Catalog number 0794P
UPC Codes:
20845357019169
Lot Numbers:
794-142-2
794-142-4
Product: KWIKSTIK, P. venetum (6-pack)
Model / REF:
Catalog number 0794K
UPC Codes:
30845357019173
Lot Numbers:
794-142-3
Product: LYFO-DISK, P. venetum
Model / REF:
Catalog number 0794L
UPC Codes:
10845357019186
Lot Numbers:
794-142-1

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93267
Status: Active
Manufacturer: Microbiologics Inc
Sold By: Microbiologics Inc
Manufactured In: United States
Units Affected: 2 products (13 units; 3 units)
Distributed To: Nationwide

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.