Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Recalled by Microbiologics Inc Due to Tests returning incorrect susceptible results. High Level Gentamicin...

Date: February 18, 2020
Company: Microbiologics Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Microbiologics Inc directly.

Affected Products

LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms

Quantity: 183 units

Why Was This Recalled?

Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Microbiologics Inc

Microbiologics Inc has 66 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report