Events

Recall of Red Blood Cell Antibody Identification Reagent - Phenocell C 0.8% and Phenocell C 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-2013-RN-00638-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-06-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00638-1
  • 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
    The antigen composition sheet supplied with the product listed cell 5 as lu-a negative. however, a customer complaint was received from the imvs adelaide red cell reference laboratory that they typed cell 5 as lua positive. confirmatory testing performed by biocsl in response to the customer complaint has confirmed that cell 5 does type as lu-a positive (weak reaction – score 5 (0-12 scale)).
  • Action
    bioCSL is providing end users with an updated Antigen Composition Sheets for affected kits. The updated information is also provided online at www.biocsl.com.au/IH

Device

Red Blood Cell Antibody Identification Reagent - Phenocell C 0.8% and Phenocell C 3%. An in vitro...
  • Model / Serial
    Red Blood Cell Antibody Identification Reagent - Phenocell C 0.8% and Phenocell C 3%. An in vitro diagnostic medical device (IVD).Phenocell C 0.8%Catalogue number: 96530201Lot number: 9653 052Phenocell C 3%Catalogue number: 86640201Lot number: 8664 052
  • Manufacturer
    bioCSL Pty Ltd

Manufacturer

bioCSL Pty Ltd