Atellica IM aTPORecalls & reported problems across all models
Siemens Healthcare Diagnostics Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Atellica IM aTPO model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of Atellica IM aTPO by Siemens Healthcare Diagnostics Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Atellica IM aTPO recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 21, 2024Open, Classified
Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.
Z-3305-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Atellica IM aTPO models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Atellica IM aTPO 10995466SYSTEM, TEST, THYROID AUTOANTIBODY1 recall0 reports
- Atellica IM aTPO 10995467SYSTEM, TEST, THYROID AUTOANTIBODY1 recall0 reports
Other Siemens Healthcare Diagnostics Inc. products
- Atellica IM TNIH2 models · 629 reports
- Dimension EXL 200 Integrated Chemistry System2 models · 516 reports · 1 recall
- Atellica IM CA 19-93 models · 121 reports · 3 recalls
- ADVIA Centaur XP Analyzer2 models · 269 reports
- ADVIA Centaur CA 19-92 models · 124 reports · 2 recalls
- Atellica IM eE23 models · 65 reports · 3 recalls
- RAPIDPoint 500 Measurement Cartridge4 models · 3 reports · 4 recalls
- ADVIA Centaur eE23 models · 22 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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