Events

Recall of VITROS CHEMISTRY PRODUCTS SYSTEM - K+ SLIDES (POTASSIUM)

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
    59925
  • Event Risk Class
    III
  • Event Initiated Date
    2013-05-14
  • 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
    While performing an internal investigation ocd determined that vitros chemistry products k+ slides coatings 0884 and 0885 contain a surfactant that was unintentionally added during the manufacturing process. the surfactant is used in several vitros slide products but it is not included in the product specifications for vitros k+ slides. ocd has conducted testing that indicates that vitros k+ slides made from coatings 0884 and 0885 are currently meeting their intended use and performance specifications. however at this time we are unable to determine the effect that the addition of the surfactant may have on long-term product performance.

Device

VITROS CHEMISTRY PRODUCTS SYSTEM - K+ SLIDES (POTASSIUM)
  • Model / Serial
    Model Catalog: 8157596 (Lot serial: 410208850657); Model Catalog: 8157596 (Lot serial: 410208840049); Model Catalog: 8157596 (Lot serial: 410208850389)
  • Product Description
    VITROS Chemistry Products Potassium (K+) Slides
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS