Events

Recall of Phenocell A 3%. 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-2014-RN-00986-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-09-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00986-1
  • 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
    A phenotyping error has been identified on the antigen composition sheet supplied with phenocel a, lot 0664933. the error relates to the colton b (cob) phenotype listed for cell 9. the antigen composition sheet supplied with these products stated cell 9 as cob negative. a complaint received by biocsl reported that cell number 9 was confirmed to be positive (cob+).
  • Action
    bioCSL is providing affected customers with an amended Antigen Composition Sheet for Phenocell A 3% Lot 0664933 which must replace the original Antigen Composition sheet. This amended Antigen Composition Sheet is also available for download via the Customer Service Portal login section on bioCSL's website: www.biocsl.com.au/IH. This action has been closed-out on 02/05/2017.

Device

Phenocell A 3%. An in vitro diagnostic medical device (IVD).
  • Model / Serial
    Phenocell A 3%. An in vitro diagnostic medical device (IVD).Item Number: 06640201Lot Number: 0664933Expiry: 29/09/2014ARTG: 223867
  • Manufacturer
    bioCSL Pty Ltd

Manufacturer

bioCSL Pty Ltd