Events

Recall of DiaMed Q.C. System. 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-01183-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01183-1
  • 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 laboratories have been made aware that samples of the product diamed q.C. system, (ihd lot 45950 46 1 and 45950 47 1) show excessive haemolysis in samples 1 and 4 and weakly in sample 2. haemolysed cells may continue to be used as long as they give the expected results. internal tests performed by bio-rad have confirmed that a clear result is returned with manual testing and on the saxo-swing, ih-1000 with the haemolysed qc samples. with ih-500 you may observe uninterpretable results on reverse grouping. in this case, please use another sample to perform the reverse grouping. note: tests involving serum 1 and serum 2 are in no way affected. the current situation has shown that the haemolysed lots will still allow the customers to perform qc testing for the following applications:- typing abo/d and phenotype rh kell- antibody screening and identification- compatibility testing.
  • Action
    1. Distribute this information with in your facility to all those who need to be aware of this notice 2. Bio-Rad kindly requests you to discard all remaining kits of these affected lots, once replacements have been received. Bio-Rad will provide a replacement once the supplied response form is received.. 3. Complete and return the supplied customer response form to Bio-Rad Laboratories as acknowledgment of receipt of this important information, even in the absence of stock. 4. If you have forwarded any product within your facility, please provide a copy of this letter to them and advise Bio-Rad Laboratories.

Device

DiaMed Q.C. System. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    DiaMed Q.C. System. An in vitro diagnostic medical device (IVD)Material Number: 45950Lot Number IHD: 45950 46 1Lot Number SAP: 166035461Expiry: 25/09/2017Lot Number IHD: 45950 47 1Lot Number SAP: 172383471Expiry: 09/10/2017ARTG Number: 232955
  • Manufacturer
    Bio-Rad Laboratories Pty Ltd

Manufacturer

Bio-Rad Laboratories Pty Ltd