FDAFDA · Food and drugs·Recall number Z-2133-2014
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Published August 6, 2014 · Recall initiated: May 27, 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
There is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- FL LA AR IA OH OH WI IL LA KS MT
- Lot
- DE271317, DE271320, DE271323, DE271324, DE271326, DE271327, DE271328, DE271332 DE271341, DE271343, DE271325, 12252589, 2004082898, 2004082899, 224719-AX
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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