Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0838-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An 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.

Product Classification:

Class II

Date Initiated: November 5, 2014

Date Posted: December 31, 2014

Recall Number: Z-0838-2015

Event ID: 69687

Reason for Recall:

Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Reagent probe performance may decline more quickly than anticipated and have an effect on assays with similar formulations when processed sequentially on the same reagent server.

Status: Terminated

Product Quantity: 1,949

Code Information:

Material Nos.: 10284473, 10488224, 10444801, and 10444802

Distribution Pattern:

Worldwide Distribution -- Austria, Australia, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Malaysia, Netherlands, New Zealand, Norway, Portugal, Republic Korea, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, and United States.

Voluntary or Mandated:

Voluntary: Firm initiated