Events

Recall of Various ID-Diacell Products. An in vitro diagnostic medical device (IVD).ID-DiaCell PoolID-DiaCell ABO/I-II ID-DiaCell ABO/I-II-III ID-DiaCell I-IIID-DiaPanelID-DiaCell I-II-IIIID-DiaCell I-II-III AsiaID-DiaScreen ProphylaxID-DiaPanel Plus 6ID-DiaCell ABOID-DiaCell lP-llP-lllPID-DiaPanel-P

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-00241-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00241-1
  • 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 has identified an issue in relation to unexpected reactions primarily on eluates and qc samples but also with some patient samples when using id-diacell products. there is the potential for false positive results.
  • Action
    Bio Rad Laboratories is advising users to re-test with a new kit if they are doubtful of the results and if doubts remain after re-testing, to use an alternative testing method. Users are further advised to disseminate this information to relevant personnel within their facilities.

Device

Various ID-Diacell Products. An in vitro diagnostic medical device (IVD).ID-DiaCell PoolID-DiaCel...
  • Model / Serial
    Various ID-Diacell Products. An in vitro diagnostic medical device (IVD).ID-DiaCell PoolID-DiaCell ABO/I-II ID-DiaCell ABO/I-II-III ID-DiaCell I-IIID-DiaPanelID-DiaCell I-II-IIIID-DiaCell I-II-III AsiaID-DiaScreen ProphylaxID-DiaPanel Plus 6ID-DiaCell ABOID-DiaCell lP-llP-lllPID-DiaPanel-P Multiple Catalogue NumbersAll unexpired lotsARTG Number: 213161
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd