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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

KWIK-STIK Quality Control Kits Recalled for Mislabeling Error

Agency Publication Date: December 2, 2025
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Summary

Microbiologics Inc is recalling 5 units of its KWIK-STIK Quality control kits (Vibrio parahaemolyticus) because they may be incorrectly labeled. Some products from lot 818-111-7 were accidentally packaged in pouches labeled with lot number 857-53-10. This error could lead to a laboratory using the wrong organism during quality control testing. Laboratory personnel should contact the manufacturer or their distributor to arrange for a return or replacement.

Risk

If a quality control kit is misidentified due to incorrect labeling, laboratory tests may use the wrong organism or batch, leading to inaccurate validation of culture media. This could potentially result in unreliable diagnostic results.

What You Should Do

  1. This recall affects KWIK-STIK Quality control kits for culture media (Vibrio parahaemolyticus derived from ATCC 17802) sold under catalog number 0818K.
  2. Identify the affected products by checking for lot number 818-111-7 or lot number 857-53-10 on the packaging pouches. The product is also identified by UDI-DI 30845357020018.
  3. Stop using the recalled product immediately.
  4. Contact Microbiologics Inc or your distributor to arrange for the return, replacement, or correction of the mislabeled kits.
  5. 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: KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802
Model / REF:
0818K
Lot Numbers:
818-111-7
857-53-10
UDI:
30845357020018

Products from lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97987
Status: Active
Manufacturer: Microbiologics Inc
Sold By: Laboratory supply distributors
Manufactured In: United States
Units Affected: 5 units

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.