Atellica CH Iron3 (Iron3) 11537211Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Iron (Iron3) Atellica CH · Class 1
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
- Mar 13, 2024Class IIOpen, Classified
Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3. Results in a positive bias ranging from 2-16% -impacts calibrator, quality control (QC), and patient results.
Z-1549-2024 · Root cause: Device Design · Recall details · FDA record ↗
Other Photometric method, iron (non-heme) devices
- Iron Gen.2 3183696122Roche Diagnostics GmbH · Photometric method, iron (non-heme)1 recall16 reports
- ADVIA® Chemistry IRON_2 Iron 2 Reagents 10377510Siemens Healthcare Diagnostics Inc. · Photometric method, iron (non-heme)1 recall1 report
- Atellica CH Iron_2 11097601Siemens Healthcare Diagnostics Inc. · Photometric method, iron (non-heme)1 recall1 report
- Alinity 08P3920Abbott Laboratories · Photometric method, iron (non-heme)1 recall0 reports
- ARCHITECT 6K95-30Abbott Laboratories · Photometric method, iron (non-heme)1 recall0 reports
- ARCHITECT 6K95-41Abbott Laboratories · Photometric method, iron (non-heme)1 recall0 reports
- ADVIA® Chemistry IRON_2 Reagents 10341118Siemens Healthcare Diagnostics Inc. · Photometric method, iron (non-heme)1 recall0 reports
- Iron Gen.2 08057931190Roche Diagnostics GmbH · Photometric method, iron (non-heme)5 reports
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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