Siemens Reagent Management System Recalled for Electrical Hazard
Siemens is recalling Reagent Management System (RMS) modules for the Dimension RxL Max clinical chemistry system because some units have missing safety covers on electrical termination blocks.
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 an exposed electrical hazard, which is a risk-of-harm product defect where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics Inc. is recalling the Reagent Management System (RMS) for the Dimension RxL Max clinical chemistry system. The RMS is a module that doubles the available storage of refrigerated Flex reagent cartridges and automatically loads, hydrates, and removes them to allow uninterrupted sample processing.
The recall is due to a safety defect where the refrigeration compressors are missing the safety cover on the electrical termination block. This creates an exposed electrical hazard located directly behind the RMS Waste Container.
The recall affects 3 units distributed nationwide in the United States, as well as in Canada and Mexico. Siemens has identified the specific units with this defect. Users of the affected systems should contact Siemens Healthcare Diagnostics Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ syst
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Hazard
- Affected units
- 3
Distribution
Part of a larger recall action
This product is one of 4 recalled by Siemens Healthcare Diagnostics Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →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 · electrical shock
See all →- HighFort Defiance Automated Field Steam Sterilizer Recalled for Electrical Grounding Defect
FDA (Devices) · 2026-08-26
- SevereJayco Recalls 2026 Seismic Fifth Wheel Toy Haulers Due to Fire Risk
NHTSA · 2026-07-02
- Severe
- HighLomi roll-on waxing kit power cords can overheat and short circuit
CPSC · 2026-06-25
- High