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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 Organism Recovery Failure

Agency Publication Date: July 29, 2025
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Summary

Microbiologics Inc. has recalled 32 units of its KWIK-STIK and LYFO-DISK diagnostic kits containing M. Canis (Derived from ATCC 36299). These kits, used by laboratories for microorganism testing, may fail to recover the target organism as required. This failure can lead to inaccurate laboratory results or failed quality control checks. No incidents or injuries have been reported in connection with this issue.

Risk

The diagnostic kits may fail to grow the intended microorganism during testing. In a laboratory environment, this can result in false-negative findings or invalid quality control data, potentially delaying clinical diagnoses or compromising laboratory standards.

What You Should Do

  1. This recall affects Microbiologics KWIK-STIK and LYFO-DISK diagnostic kits (M. Canis Derived from ATCC 36299) sold under reference numbers 0894K, 0894P, and 0894L.
  2. Check your laboratory inventory for the following lot numbers: 894-76-81, 894-76-21, 894-76-51, 894-76-52, 894-76-4, and 894-76-6. Note that all lots beginning with reference number 894-76 are impacted.
  3. Stop using the recalled product immediately. Contact Microbiologics Inc. or your distributor to arrange for a return, replacement, or correction of the affected kits.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

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: LYFO-DISK and KWIK-STIK, M. Canis Derived from ATCC 36299
Variants: REF 0894K (6-pack), REF 0894P (2-pack)
Model / REF:
0894K
0894P
Lot Numbers:
894-76-81
894-76-21
894-76-51
894-76-52
UDI:
30845357021954
20845357021940

Recall Number: Z-2194-2025. All lots of REF 894-76 are impacted.

Product: LYFO-DISK, M. Canis Derived from ATCC 36299
Variants: REF 0894L
Model / REF:
0894L
Lot Numbers:
894-76-4
894-76-6
UDI:
10845357021967

Recall Number: Z-2195-2025. All lots of REF 894-76 are impacted.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97168
Status: Active
Manufacturer: Microbiologics Inc
Sold By: Direct distribution
Manufactured In: United States
Units Affected: 32 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.