FDA Device recall Z-2133-2014
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids
- FDA Device
- Class III
- terminated
- Published 2014-08-06
On 2014-08-06 the FDA classified a Class III recall of Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids by Siemens Healthcare Diagnostics, citing there is a misassembly issue with the photometer installed on Dimension¿ Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2133-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-05-27 |
| Published | 2014-08-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | AR, FL, IA, IL, KS, LA, MT, OH, WI |
Product
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
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.
Identifiers
| code_info | DE271317, DE271320, DE271323, DE271324, DE271326, DE271327, DE271328, DE271332 DE271341, DE271343, DE271325, 12252589, 2004082898, 2004082899, 224719-AX |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2133-2014%22
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