IMMULITE® 2000 TSI 10876421Recalls & reported problems
Siemens Healthcare Diagnostics Products Ltd · IMMULITE(R) 2000 TSI Assay · 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
- Aug 11, 2022Class IIOpen, Classified
An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid
Z-1820-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other SYSTEM, TEST, THYROID AUTOANTIBODY devices
- IMMULITE® 2000 Systems ATG Anti-TG Ab (Anti-Thyroglobulin Ab) 10381659Siemens Healthcare Diagnostics Products Ltd · SYSTEM, TEST, THYROID AUTOANTIBODY1 recall17 reports
- Alinity 09P3521Abbott Ireland Diagnostics · SYSTEM, TEST, THYROID AUTOANTIBODY1 recall0 reports
- Atellica IM aTPO 10995466Siemens Healthcare Diagnostics Inc. · SYSTEM, TEST, THYROID AUTOANTIBODY1 recall0 reports
- ADVIA Centaur® aTPO 10630886Siemens Healthcare Diagnostics Inc. · SYSTEM, TEST, THYROID AUTOANTIBODY1 recall0 reports
- ARCHITECT 2K47-27Abbott Ireland Diagnostics · SYSTEM, TEST, THYROID AUTOANTIBODY1 recall0 reports
- ADVIA Centaur® aTPO +0 10630887Siemens Healthcare Diagnostics Inc. · SYSTEM, TEST, THYROID AUTOANTIBODY1 recall0 reports
- IMMULITE® 2000 Systems ATG Anti-TG Ab (Anti-Thyroglobulin Ab) 10381655Siemens Healthcare Diagnostics Products Ltd · SYSTEM, TEST, THYROID AUTOANTIBODY1 recall0 reports
- Atellica IM aTPO 10995467Siemens Healthcare Diagnostics Inc. · SYSTEM, TEST, THYROID AUTOANTIBODY1 recall0 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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