Events

Recall of Abtectcell III 0.8% and Abtectcell III 0.8% Bulk Pack. 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 bioCSL 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-2015-RN-01146-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-11-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01146-1
  • 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
    This product is a 3 cell screening panel that is used in immunohematology testing to screen patient plasma or serum samples for the presence of clinically relevant red cell alloantibodies for pre transfusion and pre-natal testing.Cell 2 when tested against weak anti e controls (i.E. securacell) during pre-acceptance testing in biovue and grifols cat platforms, is giving weak or negative reactions and not the expected mid-strength reactions. however, testing in the bio-rad (diamed) cat platform is giving the expected result.There is a potential risk that undetected weak anti-e antibody using certain cat platforms could lead to delayed hemolytic transfusion reactions (dhtr) for the patient.
  • Action
    The sponsor Seqirus is advising the users to inspect stock and quarantine all affected units prior to their return. The sponsor will arrange the replacement of the affected units or return credit. This action has been closed-out on 29/08/2016.

Device

Abtectcell III 0.8% and Abtectcell III 0.8% Bulk Pack. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Abtectcell III 0.8% and Abtectcell III 0.8% Bulk Pack. An in vitro diagnostic medical device (IVD)Abtectcell III% 0.8%Item Number: 22450201Lot Number: 2245204Expiry Date: 26/12/2015Abtectcell III% 0.8% Bulk PackItem Number: 22450205Lot Number: 2245204AExpiry Date: 26/12/2015ARTG Number: 223867
  • Manufacturer
    bioCSL Pty Ltd

Manufacturer

bioCSL Pty Ltd