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Recall Observatory FDA recall evidence

Device product

Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.

Z-2133-2014

May 27, 2014

Class III

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 68400
Status
Terminated
Classification
Class III
Quantity
15
Official record key
device-enforcement:Z-2133-2014

Official wording

Reason: 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.

Code information: DE271317, DE271320, DE271323, DE271324, DE271326, DE271327, DE271328, DE271332 DE271341, DE271343, DE271325, 12252589, 2004082898, 2004082899, 224719-AX

Distribution pattern: FL LA AR IA OH OH WI IL LA KS MT

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.