Events

Recall of VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY 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
    78223
  • Event Risk Class
    III
  • Event Initiated Date
    2013-02-19
  • 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 determined that extension springs on some vitros systems may be out of the manufacturing specifications. extension springs are part of the slide alignment guide assembly. during an internal evaluation in our manufacturing facility it was discovered that an extension spring had insufficient force. if the extension spring does not provide sufficient force microslides may not be properly positioned within the microslide incubator which has the potential to cause imprecise results. extension springs are just one component in the slide alignment assembly. our evaluation determined that the probability of an out of specification extension spring alone adversely affecting results is unlikely. to date ocd has not received any customer complaints related to this issue.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 6801375 (Lot serial: > 10 contact manufacturer); Model Catalog: 680 2445 (Lot serial: > 10 contact manufacturer); Model Catalog: 680 2413 (Lot serial: > 10 contact manufacturer)
  • Product Description
    VITROS 51 Chemistry System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS