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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-STICK Quality Control Kits Recalled for Wrong Microorganisms

Agency Publication Date: June 11, 2025
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Summary

Microbiologics Inc. is recalling 3 units of its KWIK-STICK Quality Control Kits for culture media because the products contain the incorrect microorganisms. Catalog number 01065K was mistakenly packaged with swabs intended for catalog number 0621K, and vice versa. Using the wrong control sample in a laboratory setting can lead to inaccurate test results and a delayed diagnosis for patients. No incidents or injuries have been reported, but laboratories should immediately stop using the affected kits.

Risk

The packaging error resulted in kits containing the wrong bacteria for quality control testing. If a laboratory uses these kits to verify their equipment or procedures, they may receive false results, potentially leading to incorrect or delayed medical diagnoses.

What You Should Do

  1. This recall involves Microbiologics KWIK-STICK Quality Control Kits, specifically catalog numbers 01065K (Oligella urethralis) and 0621K (Staphylococcus aureus).
  2. Check your laboratory inventory for catalog number 01065K with lot number 1065-25-51 (UDI-DI 30845357032868) and catalog number 0621K with lot number 621-73-21 (UDI-DI 30845357014666).
  3. Stop using the recalled product. Contact Microbiologics Inc. or your distributor to arrange for a return, replacement, or correction of the kits.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding medical device recalls.

Your Remedy Options

📋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-STICK, Quality control kit for culture media (Oligella urethralis derived from ATCC 17960)
Model / REF:
01065K
Lot Numbers:
1065-25-51
UDI:
30845357032868

Affected units were packaged with the incorrect microorganism swabs (contained 0621K swabs).

Product: KWIK-STICK, Quality control kit for culture media (Staphylococcus aureus derived from NCTC 12493)
Model / REF:
0621K
Lot Numbers:
621-73-21
UDI:
30845357014666

Affected units were packaged with the incorrect microorganism swabs (contained 01065K swabs).

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96974
Status: Active
Manufacturer: Microbiologics Inc
Sold By: Microbiologics Inc
Manufactured In: United States
Units Affected: 3 total
Distributed To: California, Pennsylvania

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 · 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.