Events

Recall of VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - HAPTOGLOBIN (HPT) ASSAY

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
    44723
  • Event Risk Class
    II
  • Event Initiated Date
    2012-11-05
  • 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 diagnostic (ocd) has received complaints of the inability to calibrate the vitros? chemistry products hpt reagent. ocd has also received reports of an increase in u91-274 condition codes. although all affected lots met all release testing specifications prior to distribution an ocd investigation has confirmed an increased occurrence of condition codes and calibration failures when using these lots over a period of time. ocd testing has found that as the reagent ages a potential for biased results exists if you are able to obtain a valid calibration.

Device

VITROS CHEMISTRY PRODUCTS 51 FS CHEMISTRY SYSTEM - HAPTOGLOBIN (HPT) ASSAY
  • Model / Serial
    Model Catalog: 680 2214 (Lot serial: 1533-20-2314); Model Catalog: 680 2214 (Lot serial: 1533-19-2133)
  • Product Description
    VITROS Chemistry Products HPT Reagent
  • Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS