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Legionella IFA Substrate Slides IF0951Recalls & reported problems

Diasorin Molecular LLC · Class 2

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

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

1 FDA recall record 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 15, 2017Terminated

    After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.

    Z-1686-2017 · Root cause: No Marketing Application · FDA record ↗

Other Reagents, Antibody, Legionella, Direct & Indirect Fluorescent devices

All Reagents, Antibody, Legionella, Direct & Indirect Fluorescent devices →

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