Events

Safety Alert for ID-DiaCell I-II-III Asia

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

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
    2017-09-04
  • Event Date Posted
    2017-09-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170904.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: bio-rad id-diacell i-ii-iii asia medical device manufacturer, bio-rad, has issued a medical device safety alert concerning its id-diacell i-ii-iii asia. the affected products are identified as follows:- product code: 45330 lot/serial numbers: ihd lot n°: 45330 29 1 (expiry date: 09.10.2017) / sap lot n°: 167516291 (expiry date: 11.09.2017) ihd lot n°: 45330 29 2 (expiry date: 23.10.2017) / sap lot n°: 168117292 (expiry date: 23.10.2017) ifu/um reference: b004350 version 02.15 the manufacturer has been made aware that unexpected positive reactions may occur with the cell iii of the product id-diacell i-ii-iii asia, ihd lot n° 45330 29 1 and 45330 29 2 according to the manufacture’s health risk assessment, there is no patient risk because by following the good laboratory practice practices the issue (false positive reaction) will be identified during internal quality control. the manufacturer requests customers to scrap any remaining goods of the ihd lots 45330 29 1 and 45330 29 2. the manufacturer is sending the lots 45330 30 1 respectively 45330 30 2 as a replacement in week 36. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 4 september 2017.

Device

ID-DiaCell I-II-III Asia
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Bio-Rad ID-DiaCell I-II-III Asia
  • Manufacturer
    Bio-Rad

Manufacturer

Bio-Rad