FDA-Device2014-08-06Class III
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Siemens Healthcare Diagnostics, Inc.
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.
Sold states
FL LA AR IA OH OH WI IL LA KS MT
Affected count
15
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2133-2014Don't want to check this manually?
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