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
    25193
  • Event Risk Class
    II
  • Event Initiated Date
    2011-02-21
  • 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
    Reason for the recall: instit kits that contain blotted membrane units from lot number b1a128 may produce false positive results with the instit negative control or with a patient's sample. three lots of instit were manufactured with the affected membrane units from lot b1a128: b1a135 b1a136 b1a137.

Device

INSTI HIV-1/HIV-2 ANTIBODY TEST KIT
  • Model / Serial
    Model Catalog: 90-1008 (Lot serial: B1A136); Model Catalog: 90-1007 (Lot serial: B1A136); Model Catalog: 90-1009 (Lot serial: B1A136); Model Catalog: 90-1007 (Lot serial: B1A135); Model Catalog: 90-1008 (Lot serial: B1A135); Model Catalog: 90-1009 (Lot serial: B1A135); Model Catalog: 90-1007 (Lot serial: B1A137); Model Catalog: 90-1009 (Lot serial: B1A137); Model Catalog: 90-1008 (Lot serial: B1A137)
  • Product Description
    INSTI 24 TEST KIT w/o Support Materials
  • Manufacturer
    BIOLYTICAL LABORATORIES INC.

Manufacturer

BIOLYTICAL LABORATORIES INC.