PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: December 31, 2014 Initiated: November 5, 2014 #Z-0838-2015

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.

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.

Details

Units Affected
1,949
Distribution
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.
Location
Newark, DE

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 1,949.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 31, 2014. Severity: Moderate. Recall number: Z-0838-2015.

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