FDAFDA · Food and drugs·Recall number Z-2553-2014
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.
Published September 3, 2014 · Recall initiated: July 16, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Nationwide and internationally, including Canada and Mexico
- Lot
- All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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