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LYFO DISK™ 0947LRecalls & reported problems

Microbiologics Inc. · LYFO DISK™ S. pneumoniae ATCC 49619™ · 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. Dec 16, 2020Terminated

    Contamination with S. epidermidis

    Z-0511-2022 · Root cause: Material/Component Contamination · FDA record ↗

  2. Oct 1, 2020Terminated

    Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.

    Z-0583-2022 · Root cause: Unknown/Undetermined by firm · 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.