Events

Safety Alert for NADAL hCG Pregnancy rapid test

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by nal von minden GmbH.

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
    2017-01-04
  • Event Date Posted
    2017-01-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170104.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: nal von minden nadal hcg pregnancy rapid test the medicines and healthcare products regulatory agency (mhra) of the united kingdom has posted a medical device safety alert concerning nadal hcg pregnancy rapid test [item number: 142002; lot numbers: all], manufactured by nal von minden gmbh. this safety notice concerns the limitations of the nadal hcg pregnancy rapid test, which is calibrated for intact hcg and detects intact hcg only. the proportions of intact hcg and other hcg forms in serum and urine may differ according to the stage of pregnancy in which it is analysed. according to the manufacturer, in rare cases, at a more advanced stage of pregnancy (approximately week 5-8 of pregnancy), increased amounts of hcg-beta-core fragments may be present in the urine hindering the detection reaction and leading to false negative results in spite of high hcg concentration. customers are advised to pay attention to this further limitation when evaluating the test result. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notices-19-december-23-december-2016 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 january 2017.

Device

NADAL hCG Pregnancy rapid test
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Nal von minden NADAL hCG Pregnancy rapid test
  • Manufacturer
    nal von minden GmbH

Manufacturer

nal von minden GmbH