HIGH

Microbiologics Recalls KWIK-STIK Quality Control Kit Over Labeling Issues

Microbiologics recalled the KWIK-STIK quality control kit on November 13, 2025. The recall affects five units that may have incorrect labeling. This issue may compromise the accuracy of culture media testing for Vibrio parahaemolyticus.

Quick Facts at a Glance

Recall Date
November 13, 2025
Hazard Level
HIGH
Brand
Microbiologics
Category
Health & Personal Care
Sold At
Unknown
At-Risk Groups
GENERAL

Hazard Information

Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Microbiologics Inc or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled product is the KWIK-STIK quality control kit for culture media, catalog number 0818K. The potentially affected lot number is 818-111-7. The product distributed internationally includes countries such as UAE, China, Singapore, and Kazakhstan.

The Hazard

The recall stems from products packaged under lot number 818-111-7 that may have been incorrectly labeled as lot number 857-53-10. This mislabeling poses a high hazard risk as it could lead to inaccurate testing results.

Reported Incidents

No specific incidents or injuries have been reported in connection with this recall. The potential for misdiagnosis or incorrect culture results remains a concern.

What to Do

Stop using the recalled quality control kit immediately. Follow the recall instructions provided by the manufacturer. Contact Microbiologics Inc or your healthcare provider for further instructions.

Contact Information

For more information, call Microbiologics Inc at 1-800-XXXX-XXXX or visit their website at www.microbiologics.com.

Key Facts

  • Recalled product: KWIK-STIK Quality Control Kit
  • Catalog Number: 0818K
  • Affected Lot Number: 818-111-7
  • Quantity: 5 units recalled
  • International distribution: UAE, China, Singapore, Kazakhstan

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
UDI-DI: 30845357020018
Lot Number: 818-111-7
Report Date
December 10, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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