Skip to content

LYFO DISK™ 0959LRecalls & reported problems

Microbiologics Inc. · LYFO DISK™ E. faecalis ATCC 51299™ · Class 1

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Feb 18, 2020Terminated

    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.

    Z-0586-2022 · Root cause: Process design · FDA record ↗

  2. Oct 6, 2014Terminated

    This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.

    Z-0713-2022 · Root cause: Nonconforming Material/Component · FDA record ↗

Other KIT, QUALITY CONTROL FOR CULTURE MEDIA devices

All KIT, QUALITY CONTROL FOR CULTURE MEDIA devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.