Recall Z-2088-2013 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software versions 3.5.1 and 3.6. 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 chemical and immunochemical applications use photometric
| Date | Aug 26, 2013 (initiated Jun 19, 2013) |
| Status | Terminated |
| Reason | Siemens is conducting a field correction for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.5.1 and 3.6. Under specific rare conditions which require a system reset, there is a potential for a sample to be dispensed into an aliquot well that has previously been used for a QC or calibrator product from a Vista vial. If two samples are dispensed into the same aliquot |
| Root cause | Software Design Change |
| Action | The firm, Siemens, sent an "Urgent Medical Device Correction" letter dated June 2013 to its consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to take the following actions: 1) In the event that an instrument Reset is required for any reason, review the Current Activities Screen to determine if there are any pending QC or Calibration tests. 2) If there are no pending QC of Calibration tests, Rest the instrument or troubleshoot the instrument per the Operators Guide. 3) If there are pending QC or Calibration tests, restarti |
| Quantity | 1937 |
| Distribution | Worldwide distribution: US (nationwide) including PR and countries of: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Saudia Arabia, Slovakia, Slovenia, South Africa, Spain, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051087 | DIMENSION VISTA INTEGRATED SYSTEM Dade Behring, Inc., Jul 11, 2005 |