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Alinity m 09N79-05DRecalls & reported problems

Abbott Molecular Inc. · Alinity m Resp-4-Plex Application Specification File · Class N

All models of Alinity m (13)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

  1. Sep 2, 2021Terminated

    There is a potential for false positive results.

    Z-0005-2022 · Root cause: Device Design · Recall details · FDA record ↗

  2. Sep 2, 2021Terminated

    There is a potential for false positive results.

    Z-0008-2022 · Root cause: Device Design · Recall details · FDA record ↗

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Sources and updates

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