Events

Recall of MAS OMNI IMMUNE LEVEL 2

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

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
    32379
  • Event Risk Class
    III
  • Event Initiated Date
    2016-10-03
  • 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
    The constituent inhibin a was removed from mas omni-immune and mas omni-immune pro controls however the package insert was not updated to reflect removal. the affected lots ahould not be used as control material for monitoring inhibin a assays. no other analytes of the mas omni-immune and mas omni-immune pro controls are affected.

Device

MAS OMNI IMMUNE LEVEL 2
  • Model / Serial
    Model Catalog: OIM-202 (Lot serial: OIM15092); Model Catalog: OIM-101 (Lot serial: OIM15091); Model Catalog: OPRO-202 (Lot serial: OPRO15102); Model Catalog: OPRO-SP (Lot serial: OPR1510S); Model Catalog: OPRO-303 (Lot serial: OPRO15103); Model Catalog: OIM-303 (Lot serial: OIM15093); Model Catalog: OPRO-101 (Lot serial: OPRO15101); Model Catalog: OIM-SP (Lot serial: OIM1509S)
  • Product Description
    MAS OMNI IMMUNE LEVEL 2;MAS OMNI IMMUNE LEVEL 1;MAS OMNI IMMUNE PRO LEVEL 2;MAS OMNI IMMUNE PRO;MAS OMNI IMMUNE PRO LEVEL 3;MAS OMNI IMMUNE LEVEL 3;MAS OMNI IMMUNE PRO LEVEL 1;MAS OMNI IMMUNE
  • Manufacturer
    DIAGNOSTIX LTD

Manufacturer

DIAGNOSTIX LTD