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Health product recall

Dimension Vista Systems Aliquot Plates (2013-10-30)

Starting date:
October 30, 2013
Posting date:
January 6, 2014
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-37287

Recalled products

  1. Dimension Vista Systems Aliquot Plates 

Reason

Manufacturer has confirmed intermittent Aliquot plate barcode failure to read errors causing the plate to be discarded. The error is generated when the Aliquot plate is being loaded onboard the instrument or recalled from the Aliquot elevator for an add-on test. If the Aliquot plate cannot be read, it is discarded into the waste. Not all plates within a lot exhibit the failure. Not all instruments experience failures with the same lot of Aliquot plates.

Affected products

A. Dimension Vista Systems Aliquot Plates

Lot or serial number
  • N2809513
  • N2810813
  • N2811413
  • N2817013
Model or catalog number
  • 10445210
  • KS840
Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC Drive, Mailstop 514, PO Box 6101

Newark

19714-6101

Delaware

UNITED STATES