Events

Recall of VIDAS - PROGESTERONE ASSAY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BIOMERIEUX SA.

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
    25350
  • Event Risk Class
    III
  • Event Initiated Date
    2015-03-09
  • 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
    Complaints have been received about the values of the kit control (c1) referenced in the mle card. during the investigation (pr 811293) it was discovered that the dose value range and the confidence interval of the c1 control referenced in the mle card was different than the c1 control referenced in the kits. the dose value range and the confidence interval reported in the mle card are incorrect (dose value range: 3.45 ng/ml confidence interval: 2.67-4.23 ng/ml).

Device

VIDAS - PROGESTERONE ASSAY
  • Model / Serial
    Model Catalog: 30409 (Lot serial: 1003335870)
  • Product Description
    VIDAS - PROGESTERONE ASSAY
  • Manufacturer
    BIOMERIEUX SA

Manufacturer

BIOMERIEUX SA