Events

Safety Alert for Clongene Biotech CLUNGENE hCG Pregnancy Test

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Hangzhou Clongene Biotech Co..

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
    2014-09-30
  • Event Date Posted
    2014-09-30
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140930b.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: hangzhou clongene biotech clungene hcg pregnancy test the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning clungene hcg pregnancy test, manufactured by hangzhou clongene biotech co., ltd. with the following details: lot no.: 13122001 and 14060301 types: strip, cassette and midstream the clungene hcg pregnancy test midstream (lot 13122001 and 14060301) gave 17 false positive results at 5 ireland healthcare facilities from 12th june 2014 to 7th august 2014. the manufacturer tested the reserved samples of lot13122001, lot14060301 in the factory and returned 20pcs sticks from distributor, and all test results are passed. the manufacturer revised the package insert as the old version didn’t state it unequivocal. sometimes, certain medications and endogenous substances in urine can lead to false positive results. the potentially interfering substances which will not interfere the assay when below a certain concentration were added in the new package insert as well. the manufacturer revised the package insert as the old version didn’t state it unequivocal. sometimes, certain medications and endogenous substances in urine can lead to false positive results. the potentially interfering substances which will not interfere the assay when below a certain concentration were added in the new package insert as well. for details, please refer to the following link: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con457620 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 30 sep 2014.

Device

Clongene Biotech CLUNGENE hCG Pregnancy Test
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Hangzhou Clongene Biotech CLUNGENE hCG Pregnancy Test
  • Manufacturer
    Hangzhou Clongene Biotech Co.

Manufacturer

Hangzhou Clongene Biotech Co.