FDA Device recall Z-0838-2015

Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplic…

FDA Device
Class II
terminated
Published 2014-12-31

On 2014-12-31 the FDA classified a Class II recall of Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to duplic… by Siemens Healthcare Diagnostics, citing 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 assay….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0838-2015
Classification	Class II
Status	terminated
Initiated	2014-11-05
Published	2014-12-31
Last updated	2026-09-13 11:53 UTC
Company	Siemens Healthcare Diagnostics
Distribution	n/a

Product

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

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.

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0838-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.