Events

Recall of Panocell 16 and Panocell 20. 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-2016-RN-00118-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-02-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00118-1
  • 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
    Reports have been received concerning unexpected positive reactivity when testing donor n3512 with anti-v. donor n3512 was listed as v– (negative) on the master list supplied with these products. immucor have confirmed that this donor is v+ (positive).
  • Action
    Seqirus is providing a revised master list which correctly identifies Donor N3512 as V+ (positive). Seqirus is asking users to evaluate the impact the amended phenotype information may have on results generated with these product lots as per the users' procedures. This action has been closed-out on 04/05/2017.

Device

Panocell 16 and Panocell 20. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Panocell 16 and Panocell 20. An in vitro diagnostic medical device (IVD).Panocell 16Seqirus Product Item: 2332Pack Size: 1 kit (16 cell panel)Lot Number: 39330Expiry Date: 04/12/2015Panocell 20Seqirus Product Item: 5020Pack Size: 1 kit (20 cell panel)Lot Number: 47436 (expiry 29/01/2016), 23160 (expiry 14/08/2015), 14052 (expiry 12/06/15)ARTG Number: 245555
  • Manufacturer
    bioCSL Pty Ltd

Manufacturer

bioCSL Pty Ltd