Events

Recall of VITROS 3600 IMMUNODIAGNOSTIC SYSTEM - 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
    58440
  • Event Risk Class
    III
  • Event Initiated Date
    2013-05-13
  • 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
    Ocd has received several reports of condition codes that occurred during the calibration of microwell assays. internal investigation determined that the microwell shuttle weight on some vitros systems may be uncoated and therefore out of our manufacturing specifications. if an uncoated microwell shuttle weight is installed and calibration of microwell assays is not performed biased results could potentially occur. internal testing determined that quality control results using an uncoated well weight showed on average a 10% shift from established means that was within the quality control ranges. the magnitude of the bias is not likely to impact patient safety.

Device

VITROS 3600 IMMUNODIAGNOSTIC SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 6802783 (Lot serial: 36000627); Model Catalog: 6802783 (Lot serial: 36000264); Model Catalog: 6802783 (Lot serial: 36000130); Model Catalog: 680 2413 (Lot serial: > 10 contact manufacturer)
  • Product Description
    VITROS 3600 Immunodiagnostic System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS