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
    84423
  • Event Risk Class
    III
  • Event Initiated Date
    2014-09-24
  • 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
    Siemens healthcare diagnostics is conducting a field recall for the for dimension vista hba1c and dimension hb1c flex reagent lots listed in section 64(a) of this report. siemens has confirmed that these reagent cartridge lots exhibit a positive bias averaging 0.4% [4.4 mmol/mol] hemoglobin a1c units and occasionally up to 1.0% [11 mmol/mol] hba1c units for patient samples when compared to the national glycohemoglobin standardization program (ngsp). qc samples may exhibit a similar bias. as the customer base may differ based on the platform being utilized siemens is issuing two urgent field notices: one ufsn is being issued for the affected lots of dimension vista hemoglobin a1c (hba1c). the second ufsn is being issued for the affected lots of dimension hemoglobin a1c (hb21c). customers will receive the letters pertinent to them. both letters contain the same content differing only in the specified product code and lot numbers.

Device

DIMENSION CINICAL CHEMISTRY SYSTEM - HEMOGLOBIN A1C (HB1C) ASSAY
  • Model / Serial
    Model Catalog: 10483822 (Lot serial: >10 contact mfg.); Model Catalog: DF105A (Lot serial: >10 contact mfg.); Model Catalog: 10470481 (Lot serial: >10 contact mfg.); Model Catalog: K3105A (Lot serial: >10 contact mfg.)
  • Product Description
    DIMENSION CINICAL CHEMISTRY SYSTEM - HEMOGLOBIN A
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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