Events

Recall of Phenocell B 0.8% and 3% and Abtectcell III 0.8%RhD. 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 Seqirus 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-00658-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-06-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00658-1
  • 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
    Seqirus has identified that donor #4138503 was listed as d - (negative) on the antigen composition sheet(s) provided with the affected products. subsequent testing of this donor has indicated weak d reactivity. donor #4138503 may be agglutinated by some examples of anti d and the weak d antigen expression of this donor is only detectable by some test methods. this donor has been identified as a possible weak d variant.
  • Action
    Seqirus has provided users with an interim workaround in the Customer Letter.

Device

Phenocell B 0.8% and 3% and Abtectcell III 0.8%RhD. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Phenocell B 0.8% and 3% and Abtectcell III 0.8%RhD. An in vitro diagnostic medical device (IVD)Phenocell B 0.8%Item Number: 26530201Lot Number: 2653164Cell Number: Cell #6Phenocell B 3%Item Number: 16640201Lot Number: 1664164Cell Number: Cell #6Abtectcell III 0.8% RhD Negative Screening CellsItem Number: 22230201Lot Number: 2223123Cell Number: Cell #1Expiry Date: 12/06/2017ARTG Number: 223867
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd