EliA RF IgM Well DECC056000Recalls & reported problems
Phadia AB · EliA RF IgM Well · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- May 10, 2019Terminated
Potential for reporting low assay results
Z-1907-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other SYSTEM, TEST, RHEUMATOID FACTOR devices
- Rheumatoid Factor (RF) Kit for use on SPAPLUS LK151.S.AThe Binding Site Group Limited · System, Test, Rheumatoid Factor1 recall0 reports
- Rheumatoid Factors II 5480167190Roche Diagnostics GmbH · SYSTEM, TEST, RHEUMATOID FACTOR3 reports
- Rheumatoid Factors II 20764574322Roche Diagnostics GmbH · SYSTEM, TEST, RHEUMATOID FACTOR1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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