Recall Z-2133-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
| Date | Jul 30, 2014 (initiated May 27, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| Action | An urgent field safety notice, dated May 2014, was sent to users to inform them of the issue and that a service representative would replace the misassembled photometer. |
| Quantity | 15 |
| Distribution | FL LA AR IA OH OH WI IL LA KS MT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073604 | DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD Dade Behring, Inc., Mar 13, 2008 |
| K112999 | DIMENSION CLINICAL CHEMISTRY SYSTEM Siemens Healthcare Diagnostics, Nov 22, 2011 |
| K130276 | DIMENSION EXL WITH LM SYSTEM Siemens Healthcare Diagnostics, Inc., Mar 22, 2013 |