Siemens Atellica CH Reaction Ring Segment Recalled for Cuvette Defects
Siemens Healthcare Diagnostics is recalling Atellica CH Reaction Ring Segments because defects may allow water contamination, leading to inaccurate test results.
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 is classified as FDA Class II. The hazard involves potential diagnostic errors due to contamination, which poses a risk of harm through inaccurate medical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 3,559 units of Atellica CH Reaction Ring Segments (SMN 11099326, UDI 00630414596143). The recall covers specific lots distributed domestically nationwide and worldwide.
The recall is due to potential cuvette defects in some lots ending in "17", "18", "19", or higher. These defects may allow water from the water bath to contaminate the interior of the cuvette. This contamination may falsely elevate or depress sample results, potentially affecting the accuracy of diagnostic testing.
Healthcare facilities and distributors should identify and stop using the affected lots. Siemens Healthcare Diagnostics is the recalling firm responsible for managing the recall.
The recalled product
- Product
- Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 3,559
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
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 · contamination
See all →- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls Surgical Convenience Kits Due to Contaminated Components
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02
- HighMedline Recalls Gynecologic Robotic Surgery Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline C-Section Convenience Kits Recalled for Contaminated Components
FDA (Devices) · 2026-09-02