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Siemens Healthcare Diagnostics, Inc. recalls Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Recalled August 6, 2014 · FDA recall Z-2133-2014 · Siemens Healthcare Diagnostics
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. · FDA Class III
Units
15
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Description
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.
Product
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →