HIGH

Microbiologics Recalls LYFO DISK Due to Testing Failure Risk

Microbiologics recalled LYFO DISK, Catalog Number 0325L, on December 2, 2025, after reports indicated affected units may fail to recover Campylobacter jejuni. This recall affects one unit, with an additional 16 units added on December 22, 2025. The recall impacts products distributed worldwide, including the United States.

Quick Facts at a Glance

Recall Date
December 2, 2025
Hazard Level
HIGH
Brand
Microbiologics
Category
Health & Personal Care
Sold At
Unknown
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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About This Product

LYFO DISK is a microbial identification device used in laboratories to detect specific microorganisms like Campylobacter jejuni. It is essential for accurate microbial testing in clinical settings.

Why This Is Dangerous

The affected units may not recover the target microorganism, which can lead to false negatives in microbial testing. This situation compromises patient safety and quality of care.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers relying on accurate microbial identification for health diagnostics face risks if using affected products. The urgency to stop use can disrupt laboratory operations.

Practical Guidance

How to identify if yours is affected

  1. Check the Catalog Number: 0325L
  2. Verify Lot Numbers: 325-120-5, 325-119-3, 325-119-6
  3. Review any notification letters received from Microbiologics

Where to find product info

The Catalog Number and Lot Numbers are typically printed on the product packaging or included in the user manual.

What timeline to expect

Expect 4-6 weeks for refund processing after contacting Microbiologics.

If the manufacturer is unresponsive

  • Document all communications with Microbiologics.
  • Follow up via email or phone if you do not receive a response within a week.
  • Consider reporting the issue to the FDA if there is no resolution.

How to prevent similar issues

  • Ensure products are certified for quality and safety standards before purchase.
  • Stay informed about product recalls in your industry.
  • Consult peers or industry forums for recommendations on reliable products.

Documentation advice

Keep copies of all correspondence with the manufacturer, including any emails or letters regarding the recall.

Product Details

The affected product is LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L. The recall includes Lot Numbers 325-120-5, 325-119-3, and 325-119-6. The product is distributed worldwide.

Key Facts

  • Recalled product: LYFO DISK, Catalog Number 0325L
  • Recall date: December 2, 2025
  • Distribution: Worldwide, including the US
  • Potential failure to recover Campylobacter jejuni

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

Product Classification

Product TypeMicrobial Identification Device
Sold At
Unknown

Product Details

Model Numbers
UDI-DI: 10845357006476
Lot Numbers: 325-120-5
Additional lots added 12/22/25: 325-119-3
325-119-6
Affected States
ALL
Report Date
December 31, 2025
Recall Status
ACTIVE

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