Events

Recall of VITROS CHEMISTRY PRODUCTS 51 CHEMISTRY SYSTEM - REFURBISHED INSTRUMENT

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
    14940
  • Event Risk Class
    II
  • Event Initiated Date
    2015-06-30
  • 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
    Ortho clinical diagnostics (ocd) has identified a software anomaly that may occur during the installation of an assay data diskette (add) using software versions 2.2.1 through 2.8. the anomaly is not caused by the add. ocd received two customer complaints (outside of canada) that occurred during the installation of the add... due to a software coding error for both scenarios all default settings were restored from the add instead of retaining the user configured parameters and the operator was not alerted by the system. if this anomaly occurs the vitros 51 fs system may process samples using the default reporting units from the add instead of the user modified parameters (i.E. si vs conventional units). however numerical results will be correct for the actual units reported on the vitros system.

Device

VITROS CHEMISTRY PRODUCTS 51 CHEMISTRY SYSTEM - REFURBISHED INSTRUMENT
  • Model / Serial
    Model Catalog: 6801890 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6801375 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    VITROS 51 FS CHEMISTRY SYSTEM (REFURBISHED) (LICENCE #67361)
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS