Events

Safety Alert for Pregnancy Test Cassettes and Dipsticks

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Invitech Ltd.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2014-10-28
  • Event Date Posted
    2014-10-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141028b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: invitech pregnancy test cassettes and dipsticks the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning invitech pregnancy test cassettes and dipsticks, manufactured by invitech ltd. all lots of products with code numbers inv-fhc-u101, inv-fhc-u102, inv-fhc-101, inv-fhc-102 and inv-fhc-202 were affected. the manufacturer is informing customers about a change to the reading time of all invitech pregnancy tests. the reading time for the test has been changed to ‘read results between 5 and 10 minutes after adding sample. do not read before 5 minutes or after 10’. previously, the reading time for the test was between 3 and 10 minutes after adding the sample. test lines that are very weak at 3 minutes, have better readability at 5 minutes. however any line in the test zone, no matter how faint, should be interpreted as a positive result. the manufacturer has produced a more pictorial version of the instructions. these are not intended to replace the full, written version of the instructions, but to be used as a reminder on a day to day basis. they will be included in every kit. the second stage is to revise the full, written version of the kit instructions, which is now in process. furthermore, the manufacturer advises healthcare professional using these devices to be aware of this revision to the reading time. they will be contacted to ensure they have revised worksheets and copies of the new, pictorial instructions. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con465971 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 october 2014.

Device

Pregnancy Test Cassettes and Dipsticks
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Invitech Pregnancy Test Cassettes and Dipsticks
  • Manufacturer
    Invitech Ltd

Manufacturer

Invitech Ltd