Events

Recall of ID Anti-N and ID Anti-M/N. 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-2016-RN-00373-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00373-1
  • 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 confirmed that in specific conditions, the anti-n (mns2) of certain lots of cards id-diaclon anti-n (ref. 007111) and id-diaclon anti-m/n (ref. 006011) may give an unexpected interference with n negative samples.Investigations have identified that this phenomenon is temperature dependent, becoming stronger if the ambient temperature drops to the lower range of room temperature, 18-25°c and tending to disappear once the temperature reaches the upper limit of this range. reagents and samples that are at the lower end of the room temperature range will also increase the interference.The reported issue may result in false positive results which can lead to a delay in transfusion decisions.
  • Action
    Bio-Rad is advising users NOT to validate a positive result that gives reaction strength lower than 3. The automatic validation function on the instruments should be disabled when carrying out tests MO45D and PR44N. Bio-Rad will provide manual test kits to confirm the results obtained for negative 1+ and 2+ reactions when requested. The sponsor is working on a permanent solution and the users will be notified once unaffected products become available. This action has been closed-out on 09/05/2017.

Device

ID Anti-N and ID Anti-M/N. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    ID Anti-N and ID Anti-M/N. An in vitro diagnostic medical device (IVD)ID-DiaClon Anti-N Catalogue Number: 007111Test Code (for instrument): PR44NLot Number: From lot 50221.73.01 onwardsID-DiaClon Anti-M/NCatalogue Number: 006011Test Code (for instrument): MO45DLot Number: From lot 51210.52.01 onwardsARTG Number: 217696
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd