—#85267

Product

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.

FDA product code: CDT — Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K043546, K051087
Affected lot / code info: Dimension Vista System Part Numbers 1000035896, 1000035899, 1000036563, and 1000036567. StreamLAB Analytical Workcell Part Number 746002.901 ***All StreamLAB Analytical Workcells connected to Dimension Vista Systems.

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 GBC Drive PO BOX 6101, Mailstop 514, Newark, Delaware 19714-6101

Distribution

Distribution pattern: Worldwide distribution: USA, Australia, Canada, France, Germany, Malaysia, Netherlands, Spain, and Switzerland.

Timeline

Recall initiated: 2009-09-01
Posted by FDA: 2010-03-24
Terminated: 2010-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85267. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.