Events

Recall of VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - ANALYZER CLASS-II

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
    44063
  • Event Risk Class
    II
  • Event Initiated Date
    2015-03-11
  • 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 inc. (ocd) is informing users of a software anomaly regarding microslide reagent management on the vitros 51 fs chemistry system (software version 2.8 & below). ocd has confirmed two instances where a vitros microslide cartridge was misidentified. both instances occurred when an operator accessed slide supply 1 (ss1) before the green indicator light was illuminated and subsequently proceeded to load a slide cartridge into slide supply 2. in each occurrence the loaded cartridge in slide supply 2 was misidentified. if this anomaly occurs it is possible for vitros 51 fs systems to process samples with a cartridge other than the intended cartridge potentially leading to erroneous patient results.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - ANALYZER CLASS-II
  • Model / Serial
    Model Catalog: 6801375 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6801890 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    VITROS 51 FS CHEMISTRY SYSTEM
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS