HIGH

Microbiologics Recalls KWIK-STIK Over Testing Failure Risk

Microbiologics recalled 86 units of the KWIK-STIK 2-Pack on December 2, 2025. The affected products may fail to recover the target microorganism Campylobacter jejuni. This recall affects units distributed worldwide, including the U.S.

Quick Facts at a Glance

Recall Date
December 2, 2025
Hazard Level
HIGH
Brand
Microbiologics
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

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 recall includes the KWIK-STIK 2-Pack, Catalog Number 0325P. Affected lot numbers are 325-120-3, 325-120-7, and additional lots added on December 22, 2025: 325-119-1, 325-119-5. The units are categorized as Class II.

The Hazard

Affected units may not accurately recover Campylobacter jejuni, a bacterium that can cause foodborne illness. This failure poses a risk to patients relying on accurate microbial testing.

Reported Incidents

No specific incidents have been reported. The recall is precautionary due to the potential failure of the product.

What to Do

Stop using the KWIK-STIK 2-Pack immediately. Contact Microbiologics Inc or your healthcare provider for further instructions and follow the recall guidance provided.

Contact Information

For more information, contact Microbiologics Inc. Visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0984-2026.

Key Facts

  • Recall date: December 2, 2025
  • Affected quantity: 86 units
  • Class II recall
  • Distributed worldwide
  • Contact Microbiologics for instructions

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeMicrobial Testing Kit
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI-DI: 20845357006459
Lot Numbers: 325-120-3
325-120-7
Additional Lots added 12/22/25: 325-119-1
325-119-5
Affected States
ALL
Report Date
December 31, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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