Events

Recall of INSTI HIV-1/HIV-2 ANTIBODY TEST KIT

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

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
    24590
  • Event Risk Class
    II
  • Event Initiated Date
    2010-04-30
  • 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
    Grey shading on the test area that could lead to a higher than expected incidence of false reactive insti results.

Device

INSTI HIV-1/HIV-2 ANTIBODY TEST KIT
  • Model / Serial
    Model Catalog: 90-1009 (Lot serial: 90-1009: Lot B9M146); Model Catalog: 90-1008 (Lot serial: 90-1009: Lot B9M146); Model Catalog: 90-1007 (Lot serial: 90-1009: Lot B9M146); Model Catalog: 90-1009 (Lot serial: 90-1008: Lot B9M145); Model Catalog: 90-1008 (Lot serial: 90-1008: Lot B9M145); Model Catalog: 90-1007 (Lot serial: 90-1008: Lot B9M145); Model Catalog: 90-1007 (Lot serial: 90-1007: Lot B9M144); Model Catalog: 90-1009 (Lot serial: 90-1007: Lot B9M144); Model Catalog: 90-1008 (Lot serial: 90-1007: Lot B9M144)
  • Product Description
    INSTI HIV-1/HIV-2 ANTIBODY TEST KIT
  • Manufacturer
    BIOLYTICAL LABORATORIES INC.

Manufacturer

BIOLYTICAL LABORATORIES INC.