Skip to content

AU OSR61171Recalls & reported problems

Beckman Coulter, Inc. · IgA · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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, 1 still open.

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. Jul 12, 2023Open, Classified

    Lipemic interference failed to meet the performance specification listed within the IFU.

    Z-2488-2023 · Root cause: Other · FDA record ↗

Other Method, Nephelometric, Immunoglobulins (G, A, M) devices

All Method, Nephelometric, Immunoglobulins (G, A, M) devices →

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