Events

Recall of VITROS CHEMISTRY PRODUCTS MIXING CUP ARRAYS

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
    67751
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-16
  • 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 become aware of an increase in eae condition codes when using vitros 250 or 350 chemistry systems. when customers perform an on-analyzer dilution it is performed by the vitros chemistry system using the vitros mixing cup arrays and diluents. ocd's investigation has found that while performing on-analyzer dilution some customers have reported an increase in eae conditions codes ("sample metering dilution error"). when an eae condition code occurs the processing for that patient sample is automatically cancelled by the system and the user is alerted. ocd's investigation has determined that the increased rate of eae condition codes is attributed to out-of-specification vitros mixing cup arrays. ocd is working with the oem manufacturer of the mixing cup arrays to determine the root cause of the issue.

Device

VITROS CHEMISTRY PRODUCTS MIXING CUP ARRAYS
  • Model / Serial
    Model Catalog: 1631779 (Lot serial: > 10 contact manufacturer)
  • Product Description
    VITROS Chemistry Products Mixing Cup Arrays
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS