Events

Recall of VITROS CHEMISTRY PRODUCTS SYSTEM - 250/250AT ANALYZER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ORTHO-CLINICAL DIAGNOSTICS.

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
    56619
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-22
  • 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
    Ocd has confirmed that positively biased serum or plasma sample results may occur when using vitros na+ slides gens 7-13. our data determined that the largest bias was observed when using slides from gens 7-13 when calibrated with vitros calibrator kit 2 lots 212 and 292. the amount of bias is dependent upon multiple sources of variability that include but are not limited to the slide gen calibrator kit lot calibration event and vitros system. it is important to note that not all combinations of vitros na+ slide gens and calibrator kit lots resulted in biased na+ results. customers may continue to use their remaining inventory of gens 7-13 providing the following criteria are met: (1) calibration is successful (2) quality control results are within the established range of means/acceptable limits. (3) distribution of normal results for serum or plasma samples are centered within the established reference interval for their laboratory.

Device

VITROS CHEMISTRY PRODUCTS SYSTEM - 250/250AT ANALYZER
  • Model / Serial
    Model Catalog: 1662659 (Lot serial: 212); Model Catalog: 1662659 (Lot serial: 292); Model Catalog: 8379034 (Lot serial: GENs 7 - 13)
  • Product Description
    VITROS Chemistry Products Calibrator Kit 2
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS