Recall Z-1944-2014 ยท JQP Calculator/Data Processing Module, For Clinical Use
Siemens Healthcare Diagnostics, Inc.
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
| Date | Jun 30, 2014 (initiated May 20, 2014) |
| Status | Terminated |
| Reason | Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review. |
| Root cause | Device Design |
| Action | An urgent medical device correction notice, dated May 20, 2014, was sent to end users to provide instructions to avoid potential risks associated with the software defect, until changes can be made by a Siemens technical representative. |
| Quantity | 336 |
| Distribution | Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.