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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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¿…
- 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 →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- 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
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · electrical shock
See all →- High
- Severe
- 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
Similar recalls
- SevereSiemens Dimension Reagent Management System Power Cord Recall
FDA (Devices) · 2012-08-15
- HighSiemens Dimension EXL Chemistry System Recalled for Hinge Injury Risk
FDA (Devices) · 2014-09-03
- ModerateSiemens Dimension Chemistry Systems Recalled for Non-Standard Power Plugs
FDA (Devices) · 2015-05-20
- HighSiemens Dimension Chemistry Wash Recalled for Result Shifts
FDA (Devices) · 2014-01-01
- HighSiemens Dimension Chemistry Wash Recalled for Inaccurate Test Results
FDA (Devices) · 2014-08-27
- LowSiemens Dimension EXL LM Analyzer Recalled for System Check Failures
FDA (Devices) · 2013-04-10