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.
Reported: September 3, 2014 Initiated: July 16, 2014 #Z-2553-2014
Product Description
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.
Reason for Recall
The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 2757
- Distribution
- Nationwide and internationally, including Canada and Mexico
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 2757.
Why was this product recalled? ▼
The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 3, 2014. Severity: Moderate. Recall number: Z-2553-2014.
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