Recall Z-1205-2010 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Siemens Healthcare Diagnostics, Inc.
Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers 1000035896, 1000035899, 1000036563, and 1000036567. StreamLAB Analytical Workcell Part Number 746002.901, for in vitro diagnostic use.
| Date | Mar 24, 2010 (initiated Sep 1, 2009) |
| Status | Terminated |
| Reason | Incorrect result: An intermittent low result may be seen with the last test run from an aliquot on a Dimension Vista System when connected to a StreamLAB Analytical Workcell. The sample delivery sequence may deliver insufficient surplus volume to the low sensitivity aliquot (second aliquot). The surplus sample volume is occasionally insufficient to and can cause short sampling on the last test. |
| Root cause | Software design |
| Action | Siemens healthcare Diagnostics issued an Urgent Field Safety Notice letter to each customer regarding the issue dated September 2009. The letter informed the user of the problem and volume change instructions. Customers can call Technical Solutions Center at 800-441-9250 |
| Quantity | 81 units |
| Distribution | Worldwide distribution: USA, Australia, Canada, France, Germany, Malaysia, Netherlands, Spain, and Switzerland. |
| FDA record | Open on fda.gov |