Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0430-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: May 20, 2013

Date Posted: December 11, 2013

Recall Number: Z-0430-2014

Event ID: 65408

Reason for Recall:

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

Status: Terminated

Product Quantity: 776

Code Information:

Dimension Vista(R) 500 - Siemens Material Number 10284473 and Dimension Vista(R) 1500 - Siemens Material Number 10444801

Distribution Pattern:

Worldwide Distribution: USA (nationwide) and iinternationally to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated