Events

Safety Alert for NaOHD and Hitergent Cassettes

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Roche Diagnostics 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
    2013-02-19
  • Event Date Posted
    2013-02-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130219a.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 naohd and hitergent cassettes medical device manufacturer, roche diagnostics gmbh issued a medical device safety alert concerning the following products: naohd (for c702)- catalogue no.: 05172128 190; lot no.: 669088 and 663099 hitergent (for c702)- catalogue no.: 05172101 190; lot no.: 666210 according to roche, some of the lots listed above may have micro-leakage. internal investigation revealed that the frequency of the micro-leakage showed in 1 out of 8000 cassettes.  users are suggested to check whether the cellophane wrapping of the cassettes are wet before loading to the reagent manager. according to roche, all further product lots will undergo a 100% leakage check during the manufacturing process, and reimbursement or replacement can be offered in case of product leaking. according to the local supplier, roche diagnostics (hong kong) limited, the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 february 2013.

Device

NaOHD and Hitergent Cassettes
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Roche NaOHD and Hitergent Cassettes
  • Manufacturer
    Roche Diagnostics GmbH

Manufacturer

Roche Diagnostics GmbH