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Health product recall

Dimension Vista System (2015-05-20)

Starting date:
May 20, 2015
Posting date:
June 15, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-53799

Recalled Products

  1. Dimension Vista System - Dimension Vista 1500 Analyzer
  2. Dimension Vista System - Dimension Vista1500
  3. Dimension Vista System - Dimension Vista 500

Reason

Issue # 1: Manufacturer received complaints for samples not processing without notification on the Dimension Vista 500 or Dimension Vista 1500 using software versions 3.6.1 in most cases, user action of pause / cancel pause is effective in restoring lane operation and the samples will resume processing. However in a few cases it was necessary to shutdown the instrument software and restart to recover. In all cases the affected samples are resubmitted and run successfully.

Issue # 2: Manufacturer received complaints for unexpected less than lower assay range (< l) or results that were flagged with assay errors on Dimension Vista 1500 systems using software versions 3.6.1. Result data and the physical evidence from flexes suggested that a reagent server lost synchronization and the software was unaware of the problem.

Affected products

A. Dimension Vista System - Dimension Vista 1500 Analyzer

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 1000033793
Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
500 Gbc Drive, Mailstop 514
Newark, Delaware
19714-6101
UNITED STATES

B. Dimension Vista System - Dimension Vista1500

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

Not applicable

Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
500 Gbc Drive, Mailstop 514
Newark, Delaware
19714-6101
UNITED STATES

C. Dimension Vista System - Dimension Vista 500

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 1000034648
Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
500 Gbc Drive, Mailstop 514
Newark, Delaware
19714-6101
UNITED STATES

Date modified: