Siemens Atellica CH 930 Analyzer Recalled for Calibration Error
Siemens Healthcare Diagnostics is recalling 1,432 Atellica CH 930 Analyzers due to a potential calibration error that may cause results to be five times higher than expected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (incorrect patient results) where no specific injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,432 units of the Atellica CH 930 Analyzer. The recall is due to a potential for calibration error that can result in quality control failures after a calibration run, with quality control and patient results being five times higher than expected.
The affected units are identified by Software V1.20.0 and lower, with UDI 00630414002163. The devices were distributed to accounts in numerous US states and territories, as well as to foreign locations including Australia, Brazil, Canada, China, Germany, India, Japan, and the United Kingdom.
Healthcare facilities and consumers should stop using the affected analyzers and contact Siemens Healthcare Diagnostics for further instructions on the recall.
The recalled product
- Product
- Atellica CH 930 Analyzer
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 1,432
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- SMN 11067000
- Software V1.20.0 and Lower
- UDI 00630414002163
Distribution
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · calibration error
See all →- ModeratePhotera 400 Phototherapy Device Recalled for Incorrect UV Sensor Calibration
FDA (Devices) · 2026-07-22
- ModeratePhotera 600 Phototherapy Device UV Sensor Calibration Error
FDA (Devices) · 2026-07-22
- ModeratePhotera 600 3-D phototherapy device UV sensor calibration error recall
FDA (Devices) · 2026-07-22
- HighPhothera 200 phototherapy calibration certificates had outputs reversed
FDA (Devices) · 2026-06-10
- HighRoche cobas analyzer may repeat previous results for spline calibrated assays
FDA (Devices) · 2026-03-11