Events

Recall of BIOSTRIP HCG ONE STEP URINE PREGNANCY TEST

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH CANADA 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
    51677
  • Event Risk Class
    III
  • Event Initiated Date
    2010-04-26
  • 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 biostrip hcg one step pregnancy test had been labelled with an incorrect lot number on the test kit box. the cans inside the kit box which hold the pregnancy test strips have been labelled correctly with lot # 5-02180. expiry date is correctly printed. there has been no deterioration in the health of any users. only test kit with lot # 5-02080 marked on the box are being recalled.

Device

BIOSTRIP HCG ONE STEP URINE PREGNANCY TEST
  • Model / Serial
    Model Catalog: (Lot serial: 5-02180); Model Catalog: (Lot serial: 5-02080)
  • Product Description
    Biostrip HCG Onse Step Urine Pregnancy
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Manufacturer Address
    CONCORD
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC