Events

Safety Alert for IRISpec CA/CB/CC and IRISpec CA/CB

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

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
    2016-04-18
  • Event Date Posted
    2016-04-18
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160418a.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: iris international irispec ca/cb/cc and irispec ca/cb medical device manufacturer, iris international, has issued a medical device safety alert concerning its irispec ca/cb/cc and irispec ca/cb. the affected products are identified as follows:- reference number: 800-7211 lot numbers: 336-15, 343-15 (exp april 2016) lot numbers: 004-16,006-16,019-16,021-16,182-15 (exp may 2016) reference number: 800-7702 lot numbers: 313-15, 336-15 (exp april 2016) lot numbers: 004-16 (exp may 2016) reference number: 800-0074 lot number: 309-15 (exp april 2016) the manufacturer has become aware of an issue in which premature degradation of bilirubin for specific lots may lead to bilirubin control failures for the irispec ca bilirubin control material. the control may fail for the bilirubin analyte and laboratories will be unable to process patient samples until qc passes. there is no impact to patient results. the manufacturer is advising users to ensure the directions for handling and storage of the control material as per the instructions for use are followed to prevent premature degradation of the control material. users are advised to discard the bottle if the irispec ca control for bilirubin fails and use alternative bottles in the kit. if the problem persists, users are advised to request a product replacement from the manufacturer. 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 18 april 2016.

Device

IRISpec CA/CB/CC and IRISpec CA/CB
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Iris International IRISpec CA/CB/CC and IRISpec CA/CB
  • Manufacturer
    Iris International

Manufacturer

Iris International