Siemens Dimension EXL Chemistry System Recalled for Hinge Injury Risk
Siemens is recalling 2,757 Dimension EXL Integrated Chemistry Systems because a reagent lid hinge may shift during maintenance, posing a risk of physical injury to operators.
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 a risk-of-harm product (physical injury to operator) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 2,757 units of the Siemens Dimension EXL Integrated Chemistry System. These in vitro diagnostic devices are intended to measure various analytes in human body fluids. The recall covers all serial numbers for material numbers 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.
The recall was initiated because the reagent lid hinge may lose effectiveness and slowly shift downward during maintenance procedures. This mechanical failure could result in physical contact and injury to the operator. The affected units were distributed nationwide and internationally, including in Canada and Mexico.
The source text does not specify a particular action for consumers or operators beyond the recall notice itself. Users of these devices should contact Siemens Healthcare Diagnostics, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 2,757
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 (6)
- All Serial #s of material #s: 10636929
- 10636928
- 10486890
- 10472176
- 10639337
- and 10639338
Distribution
Distributed nationwide across the United States.
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