Recall Z-1046-2013 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety of analytes in human body fluids.
| Date | Apr 1, 2013 (initiated Feb 27, 2013) |
| Status | Terminated |
| Reason | Through investigation of customer complaints, Siemens Healthcare Diagnostics has confirmed an increase in System Check failures due to high System Check LOCI results. Upon further investigation, Siemens has determined that many of these errors are due to the current limit set for System Check LOCI results. The errors have no impact on results, but they may cause customer inconvenience. Siemens h |
| Root cause | Under Investigation by firm |
| Action | Siemens initiated their recall of this product on February 27, 2013 by sending an Important Customer Notification letter to consignees by FedEx. The letter identified the product, problem, and actions to be taken by the customers. |
| Quantity | 2207 total |
| Distribution | Worldwide Distribution. |
| 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 |