Events

Recall of DIMENSION CINICAL CHEMISTRY SYSTEM - HEMOGLOBIN A1C (HB1C) 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
    84421
  • Event Risk Class
    III
  • Event Initiated Date
    2013-08-10
  • 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
    Customers have been experiencing a higher frequency of "above assay range" flags on patient samples with the dimension? hb1c method. upon dilution the result is usually well within the range of the assay. some customers understand the issue is hemoglobin being above the assay range of > 25 g/dl and have verified on an independent system that hemoglobin on affected samples are < 25 g/dl. some customers have experienced a high bias on us cap survey samples (2012 gh2-b) with the hb1c method. cap samples that failed are in the normal range of the method.

Device

DIMENSION CINICAL CHEMISTRY SYSTEM - HEMOGLOBIN A1C (HB1C) ASSAY
  • Model / Serial
    Model Catalog: DF105A (Lot serial: ); Model Catalog: DF105A (Lot serial: >10 CONTACT MFR)
  • Product Description
    DIMENSION HEMOGLOBIN A1C (HB1C) ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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