Events

Safety Alert for IRISpec CA/CB/CC control

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

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
    2017-08-30
  • Event Date Posted
    2017-08-30
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170830.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: beckman coulter irispec ca/cb/cc control beckman coulter has issued a medical device safety alert concerning the irispec ca/cb/cc control, manufactured by iris diagnostics. [reference numbers: 800-7702 and 800-7702-fjr]. the manufacturer has become aware of an issue in which results for the irispec cb control for urobilinogen may fall below the lower limit of the stated quality control range. the irispec cb control may intermittently fail for the urobilinogen analyte when run on the ichemvelocity. the customer’s laboratory will be unable to process patient samples until quality control passes. this will not affect patient sample results. a new lower limit on the urobilinogen control range is being implemented to align the published ifu range with that of the allowable product claims per beckman coulter’s design requirements. the irispec ca/cb/cc package insert (and strip package insert information related to controls) will be updated to reflect changes to the lower limit of the qc range. customers are recommended to take the following actions: implement the use of the following revised quality control ranges for irispec cb urobilinogen for the ichemvelocity refer to the ichemvelocity operato’s manual (p/n 300-4449fe, appendix a; entering consumables data) to change the qc range or contact the manufacturer for assistance. disregard any information related to control specifications that are outlined in strip package insert. 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 30 august 2017.

Device

IRISpec CA/CB/CC control
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Beckman Coulter IRISpec CA/CB/CC control
  • Manufacturer
    Iris Diagnostics.

Manufacturer

Iris Diagnostics.