Atellica CH IgM_2 11097620Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Immunoglobulin M ( IgM_2) Atellica CH - RGT 720T · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Dec 15, 2023Class IIOpen, Classified
Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
Z-1003-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M) devices
- AU OSR61173Beckman Coulter, Inc. · Method, Nephelometric, Immunoglobulins (G, A, M)1 recall0 reports
- IMMAGE 447610Beckman Coulter, Inc. · Method, Nephelometric, Immunoglobulins (G, A, M)1 recall0 reports
- AU OSR61171Beckman Coulter, Inc. · Method, Nephelometric, Immunoglobulins (G, A, M)1 recall0 reports
- ADVIA® Chemistry IGM_2 Reagents 10309032Siemens Healthcare Diagnostics Inc. · METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)2 reports
- VITROS 6801732Ortho-Clinical Diagnostics, Inc. · METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)1 report
- Immunoglobulin M 20737771322Roche Diagnostics GmbH · METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)1 report
- N Antisera to Human IgM 10446303Siemens Healthcare Diagnostics Products GmbH · METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)1 report
- DImension Vista® Immunoglobulin M Flex® reagent cartridge 10445904Siemens Healthcare Diagnostics Products GmbH · METHOD, NEPHELOMETRIC, IMMUNOGLOBULINS (G, A, M)1 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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