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
    25038
  • Event Risk Class
    III
  • Event Initiated Date
    2015-11-16
  • 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 issued this recall due to a software anomaly that may potentially occur on vitros 4600 or 51 fs systems. ocd recently identified that under very specific conditions the temperature in the microwell subsystem (included on vitros 3600 and 5600 systems) may potentially be out of range without the system properly alerting the operator. although vitros 4600 and 51 fs systems do not include a microwell subsystem it utilizes the same software as vitros 3600 and 5600 systems. ocd has estimated that there is a less than 1 in 14 million possibility that this anomaly could occur in the microslide or microtip subsystems included on vitros 4600 or 51 fs systems.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - INSTRUMENT
  • Model / Serial
    Model Catalog: 680 1375 (Lot serial: > 10 contact manufacturer); Model Catalog: 680 2445 (Lot serial: > 10 contact manufacturer)
  • Product Description
    VITROS 51 FS Chemistry System
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS