Events

Recall of Ready-Prep %CDT by HPLC using the CDM software version MVC133091. 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-2017-RN-01532-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-12-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01532-1
  • 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
    Bio-rad have observed that the lot numbers for mobile phase 2 [mp][2] and mobile phase 3 [mp][3] on the cd-rom cover print and within the method for the cdm software are not correct for the affetced cd-rom, due to a defect in the manufacturing process of the cd-rom.Thus, the printed numbers on the cd-rom do not correspond to the correct lot numbers of mobile phase 2 and mobile phase 3 which were delivered with the associated kits.The wrong lot numbers within the cdm method will affect only customers using the cdm software: the wrong lot numbers within the method of the cdm software will result in transfer of the wrong lot numbers into the users cdm software, and false lot numbers printed in the summary reports of the analytical runs. this may result in difficulties of the traceability of used mobile phases. due to the fact that the wrong lot numbers are not used for any other reagents or components of any %cdt by hplc test there is no risk of false traceability.
  • Action
    Bio-Rad is advising users to immediately check the documentation obtained by using the CD-ROM of the affected lots. If users have used the CD-ROM to read in the lot numbers into the CDM software, correct the MP2 and 3 lot numbers in the CDM software manually (as described in the CDM manual Version 4.0, chapter 5.1.4). Alternatively, discontinue use of the CD-ROM and Bio-Rad will replace the CD-ROM when the quality issue is resolved.

Device

Ready-Prep %CDT by HPLC using the CDM software version MVC133091. An in vitro diagnostic medical ...
  • Model / Serial
    Ready-Prep %CDT by HPLC using the CDM software version MVC133091. An in vitro diagnostic medical device (IVD)Catalogue Number: 1956670, 1956671Serial numbers: 64121977, 64139856, 64139684, 64142119, 64121979Expiry Date: 15-03-2018ARTG Number: 194835
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd