Events

Recall of VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - ANALYZER CLASS-II

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
    22543
  • Event Risk Class
    II
  • Event Initiated Date
    2015-04-07
  • 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 inc. (ocd) has confirmed instances where the vitros system allowed urine samples for assays that required acidified pretreatment to be metered from the same sample container as assays that required no pretreatment when the sample was programmed. this has been attributed to a software anomaly. depending upon the assay urine samples either need to be acidified alkalized or require no pretreatment. the anomaly occurs when manually programming urine samples or using a downloaded sample program from a laboratory information system (lis) and the sample program contains assays requiring sample pretreatment and assays requiring no sample pretreatment. if this anomaly occurs it is possible for vitros 51 4600 or 5600 systems to process urine samples without the proper pretreatment potentially leading to biased patient results.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - ANALYZER CLASS-II
  • Model / Serial
    Model Catalog: 6801890 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6802413 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6801375 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 6802445 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    VITROS 51 FS CHEMISTRY (DEVICE LICENCE #66236)
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS