Events

Recall of DIMENSION VISTA SYSTEMS ALIQUOT PLATES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS HEALTHCARE LIMITED.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56204
  • Event Risk Class
    III
  • Event Initiated Date
    2013-10-30
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • 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.

Device

DIMENSION VISTA SYSTEMS ALIQUOT PLATES
  • Model / Serial
    Model Catalog: 10445210 (Lot serial: N2809513); Model Catalog: KS840 (Lot serial: N2810813); Model Catalog: 10445210 (Lot serial: N2810813); Model Catalog: 10445210 (Lot serial: N2811413); Model Catalog: KS840 (Lot serial: N2817013); Model Catalog: 10445210 (Lot serial: N2817013); Model Catalog: KS840 (Lot serial: N2809513); Model Catalog: KS840 (Lot serial: N2811413)
  • Product Description
    DIMENSION VISTA SYSTEMS ALIQUOT PLATES
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC