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
    57846
  • Event Risk Class
    III
  • Event Initiated Date
    2012-08-17
  • 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
    There has been a change to the acceptable range for the 'e' calibration coefficient guideline. the new guideline range is 5 to 8 (conventional units). the guideline range for lots prior to ga3099 is 6 to 9. the e coefficient range is a criterion used by customers to assess the validity of their calibration. siemens has also noted that some users are not updating scaler values when setting up a calibration (this was implemented beginning with lot ga3009) resulting in inaccurate values for both patients and controls.

Device

DIMENSION CINICAL CHEMISTRY SYSTEM - HEMOGLOBIN A1C (HB1C) ASSAY
  • Model / Serial
    Model Catalog: DF105A (Lot serial: GA3099); Model Catalog: DF105A (Lot serial: GA3169); Model Catalog: DF105A (Lot serial: GA3141); Model Catalog: DF105A (Lot serial: GA3134); Model Catalog: DF105A (Lot serial: GA3113); Model Catalog: DF105A (Lot serial: GA3162)
  • Product Description
    DIMENSION HEMOGLOBIN A1C FLEX REAGENT
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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