Events

Recall of DIMENSION VISTA SYSTEM - HEMOGLOBIN A1C (HBA1C) ASSAY

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
    56973
  • Event Risk Class
    III
  • Event Initiated Date
    2014-08-19
  • 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
    An internal study has show that variance is introduced into the % hba1c result when the sample is run from the small sample container (ssc). previously (vc-14-03) cyclosporine was identified as under-recovering when run from the ssc. capa investigation has found that an unintentional dilution of the sample occurs when whole blood samples are transferred from the ssc to the aliquot well. %hba1c is a ration of two components. with the % hba1c the unintentional dilution of sample introduces variance into the final %hba1c result.

Device

DIMENSION VISTA SYSTEM - HEMOGLOBIN A1C (HBA1C) ASSAY
  • Model / Serial
    Model Catalog: K3105A (Lot serial: 14041BA); Model Catalog: 10470481 (Lot serial: 14132BA); Model Catalog: K3105A (Lot serial: 14132BA); Model Catalog: 10470481 (Lot serial: 14041BA); Model Catalog: 10470481 (Lot serial: 13273BA); Model Catalog: K3105A (Lot serial: 13273BA); Model Catalog: 10470481 (Lot serial: 13294BA); Model Catalog: K3105A (Lot serial: 13294BA); Model Catalog: 10470481 (Lot serial: 13308BA); Model Catalog: K3105A (Lot serial: 13308BA); Model Catalog: 10470481 (Lot serial: 13329AA); Model Catalog: K3105A (Lot serial: 13329AA); Model Catalog: 10470481 (Lot serial: 13350AA); Model Catalog: K3105A (Lot serial: 13350AA); Model Catalog: K3105A (Lot serial: 14006AA); Model Catalog: 10470481 (Lot serial: 14006AA)
  • Product Description
    Dimension Vista System-Hemoglobin A1C (HBA1C) A
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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