Recall Z-1454-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 The Dimension Vista(R) System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista(R) chemical and immunochemical applications use photometric, turbidime
| Date | Apr 25, 2012 (initiated Jan 16, 2012) |
| Status | Terminated |
| Reason | Siemens has confirmed customer complaints on Vista(R) software version 3.4 for Below Manufacturer Assay Range error flags associated with QC and patient test results that are within the assay range as defined in the Instructions For Use for the respective method. This issue is isolated to Vista(R) software version 3.4. Customers who have not made any changes to the default method configurations |
| Root cause | Software change control |
| Action | Siemens sent an Urgent Field Safety Notice dated December 19, 2011 to all affected customers alerting them to Invalid Below Manufacturer Assay Range Flags on Dimension Vista(R) Systems with Software Version 3.4. The UFSN included instructions on how to correct the situation and also included an effectiveness check form to be faxed to the firm at 302-631-8467. On January 16, 2012, the firm issued an additional UFSN alerting consignees to Invalid Above and Below Manufacturer Assay Range Flags. This notice also included directions and a Field Correction Effectiveness Check form to be completed |
| Quantity | 1,683 |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland & Baltics, France, Germany, Italy, Japan, South Korea, Malaysia, Netherlands, New Zealand, Norway, Portugal, Puerto Rico, Saudi Arabia, Slovakia, Slovenia, South Afric |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051087 | DIMENSION VISTA INTEGRATED SYSTEM Dade Behring, Inc., Jul 11, 2005 |