FDAFDA · Food and drugs·Recall number Z-0430-2014
Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1. Diagnostic device intended to determine a variety of analytes in human body fluids.
Published December 11, 2013 · Recall initiated: May 20, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is the potential for the vial volume of "in use" Vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded. Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using software versions 3.4 and 3.5.1
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- Worldwide Distribution: USA (nationwide) and iinternationally to Canada.
- Lot
- Dimension Vista(R) 500 - Siemens Material Number 10284473 and Dimension Vista(R) 1500 - Siemens Material Number 10444801
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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