Events

Safety Alert for UREA/BUN for Modular system

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

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
    2015-04-09
  • Event Date Posted
    2015-04-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150408.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: roche urea/bun for modular system medical device manufacturer, roche, has issued a medical device safety alert concerning its urea/ blood urea nitrogen (urea/bun) for modular system. the affected reference numbers are 11729691216, 11929470216, 11929488216, 11929496216, 11929500216 and 11489364216. according to the manufacturer, rounding error occurred during calculation of measuring ranges and technical limits in different units. the error leads wrong measuring ranges and technical limits being stated in the instruction of use and setting in the analyzers. thus, these values have to be corrected as well as harmonized in case where the values stated in the parking insert and setting is not coherent the manufacturer has corrected the measuring range and technical limit for urea/urea nitrogen assay and harmonized in the packing insert as well as in the settings for serum and urine for modular analytics p and d. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 april 2015.

Device

UREA/BUN for Modular system
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Roche UREA/BUN for Modular system
  • Manufacturer
    Roche

Manufacturer

Roche