Events

Recall of VITROS CHEMISTRY PRODUCTS SYSTEM - CREA SLIDES (CREATININE)

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
    104022
  • Event Risk Class
    III
  • Event Initiated Date
    2013-06-14
  • 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
    Ocd has received an increase in customer complaints related to slide dispense issues with some vitros chemistry products slides. this increase is due to the anti-backup platen (abp) failing to advance inside the vitros chemistry products slide cartridge body causing an increase in condition codes on the vitros system. the abp is a plastic platform that supports the slide stack inside the cartridge and is pushed along with the slides to the top of the cartridge during the slide dispense cycle. if the abp is jammed within the cartridge body a slide will not be properly positioned to dispense and the system will generate a condition code. this can lead to system downtime as the user must remove the cartridge and re-seat the abp in the slide cartridge or replace it with a new cartridge.

Device

VITROS CHEMISTRY PRODUCTS SYSTEM - CREA SLIDES (CREATININE)
  • Model / Serial
    Model Catalog: 680 2584 (Lot serial: > 10 contact manufacturer); Model Catalog: 1988211 (Lot serial: > 10 contact manufacturer); Model Catalog: 8343386 (Lot serial: > 10 contact manufacturer); Model Catalog: 6801895 (Lot serial: > 10 contact manufacturer); Model Catalog: 1053180 (Lot serial: > 10 contact manufacturer); Model Catalog: 8102204 (Lot serial: > 10 contact manufacturer); Model Catalog: 8001133 (Lot serial: > 10 contact manufacturer); Model Catalog: 8058232 (Lot serial: > 10 contact manufacturer); Model Catalog: 8297749 (Lot serial: > 10 contact manufacturer); Model Catalog: 8159931 (Lot serial: > 10 contact manufacturer); Model Catalog: 1668409 (Lot serial: > 10 contact manufacturer); Model Catalog: 1707801 (Lot serial: > 10 contact manufacturer); Model Catalog: 1921204 (Lot serial: > 10 contact manufacturer); Model Catalog: 8255093 (Lot serial: > 10 contact manufacturer); Model Catalog: 1612365 (Lot serial: > 10 contact manufacturer); Model Catalog: 8383051 (Lot serial: > 10 contact manufacturer)
  • Product Description
    VITROS CREA Slides
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS