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Health product recall

Dimension Vista 500 and 1500 Analyzers

Starting date:
May 24, 2013
Posting date:
July 23, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-34225

Recalled products

  1. Dimension Vista 1500 Analyzer
  2. Dimension Vista 500 Analyzer

Reason

Siemens is conducting a recall for Dimension Vista 500 and Dimension Vista 1500 systems using software versions 3.4 and 3.5.1. There is a potential for the vial volume of in-use vista calibrators, controls, or sample diluent to incorrectly revert to full volume when removed and reloaded.

Affected products

A. 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, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES

B. Dimension Vista 500 Analyzer

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, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES