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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: KWIK-STIK Positive Control Materials Recalled for Fungal Contamination

Agency Publication Date: April 5, 2024
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Summary

Microbiologics Inc. is recalling 19 units of its KWIK-STIK Rhizopus stolonifer (+) quality control kits because the control material was contaminated with a different fungal organism, Aspergillus brasiliensis. This contamination means that laboratories using these kits to verify their culture media may see the wrong type of fungal growth, leading to inaccurate quality control results. These kits were distributed to several states including Michigan, Kentucky, and Missouri, as well as several international locations.

Risk

The presence of unintended Aspergillus brasiliensis growth instead of the expected Rhizopus stolonifer can cause laboratories to incorrectly validate their testing processes. This contamination may lead to false-positive or misleading results in clinical or industrial quality control settings.

What You Should Do

  1. Identify your product by checking the REF number and Lot numbers on the packaging for KWIK-STIK Rhizopus stolonifer (+) kits.
  2. For product 'a' (REF 0209P / UDI 20845357003113), check for Lot Numbers: 209-37-1, 209-37-3, 209-37-4, or 209-37-5.
  3. For product 'b' (REF 0209K / UDI 30845357003127), check for Lot Number: 209-37-2.
  4. Immediately stop using any affected control materials from these specific lots.
  5. Contact your healthcare provider or Microbiologics Inc. at 200 Cooper Ave N, Saint Cloud, MN 56303 for specific instructions on how to return or dispose of the contaminated kits and to receive a replacement or refund.
  6. Call the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer instructions for contaminated device

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

Affected Products

Product: KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b (REF 0209P)
Model / REF:
REF 0209P
UDI/DI 20845357003113
Lot Numbers:
209-37-1
209-37-3
209-37-4
209-37-5
Product: KWIK-STIK Rhizopus stolonifer (+) derived from ATCC 6227b (REF 0209K)
Model / REF:
REF 0209K
UDI/DI 30845357003127
Lot Numbers:
209-37-2

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94201
Status: Active
Manufacturer: Microbiologics Inc
Manufactured In: United States
Units Affected: 19 units
Distributed To: California, Michigan, Kentucky, Missouri, New Mexico, Tennessee, Puerto Rico

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.