Events

Recall of IH-1000 with software version 04.07.02. An in vitro diagnostic medical device (IVD)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bio-Rad Laboratories Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00245-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-03-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00245-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    It has been identified that when a reagent vial with an unreadable barcode is loaded on a reagents rack on ih-1000 (software version 04.07.02) and a test is performed, despite the fact the first reagent is correctly pipetted, the instrument will pipette from the vial with unreadable barcode for all the remaining wells. the system will add serum and continue as normal without alarm.This error happens following a specific sequence of events:1. use ih-1000 in version 04.07.022. load a reagent in a reagent rack3. the barcode on the reagent vial is not readable4. perform a test requiring the reagent with the unreadable barcode 5. validate the results through ih-com.
  • Action
    BioRad is advising customers to restore the previous version of software 04.04.08. Users may contact Bio-Rad Laboratories to arrange for replacement software. BioRad is advising users to review previous results obtained since the installation of the affected software version. This can be done by checking the lot numbers in the daily journal in IH-Com. If the lot number does not appear do not use the test results and perform the test again.

Device

IH-1000 with software version 04.07.02. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    IH-1000 with software version 04.07.02. An in vitro diagnostic medical device (IVD)Catalogue Number: 001000ARTG Number: 184446(Bio-Rad Laboratories - Instrument/analyser IVDs)
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd