Events

Recall of DIMENSION CLINICAL CHEMISTRY SYSTEM - ENZYMLE IICALIBRATOR (ENZ II CAL)

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
    80206
  • Event Risk Class
    III
  • Event Initiated Date
    2016-05-13
  • 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 has received complaints of positive shift of patient and qc results when the alti assay is calibrated with specific lots of dimension enzyme ii calibrator. internal investigation has confirmed that patients quality control and proficiency testing material all demonstrate a similar shift of up to 10% in comparison to results obtained using earlier calibrator lots. the shift began with lot 4md047.

Device

DIMENSION CLINICAL CHEMISTRY SYSTEM - ENZYMLE IICALIBRATOR (ENZ II CAL)
  • Model / Serial
    Model Catalog: DC143 (Lot serial: 6AD054); Model Catalog: 10476170 (Lot serial: 4MD047); Model Catalog: DC143 (Lot serial: 5LD051); Model Catalog: 10476170 (Lot serial: 5LD051); Model Catalog: DC143 (Lot serial: 5JD069); Model Catalog: 10476170 (Lot serial: 5JD069); Model Catalog: DC143 (Lot serial: 5HD010); Model Catalog: 10476170 (Lot serial: 5HD010); Model Catalog: DC143 (Lot serial: 5GD050); Model Catalog: 10476170 (Lot serial: 5GD050); Model Catalog: DC143 (Lot serial: 5FD017); Model Catalog: 10476170 (Lot serial: 5FD017); Model Catalog: DC143 (Lot serial: 4MD047); Model Catalog: DC143 (Lot serial: 5CD052); Model Catalog: 10476170 (Lot serial: 5CD052); Model Catalog: 10476170 (Lot serial: 6AD054); Model Catalog: 10475527 (Lot serial: 5DD026); Model Catalog: KC321 (Lot serial: 5DD026); Model Catalog: 10475527 (Lot serial: 5LD061); Model Catalog: KC321 (Lot serial: 5LD061); Model Catalog: 10475527 (Lot serial: 5JD058); Model Catalog: KC321 (Lot serial: 5JD058); Model Catalog: 10475527 (Lot serial: 5GD004)
  • Product Description
    DIMENSION CLINICAL CHEMISTRY SYSTEM- ENZYME II CALBIBRATOR (ENZ II CAL);DIMENSION XPAND SYSTEM-ENZYME II CALIBRATOR (ENZ II CAL);DIMENSION EXL SYSTEM-ENZYME II CALIBRATOR (ENZ II CAL);DIMENSION VISTA SYSTEM- ENZYME CALIBRATOR
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

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