Events

Recall of BioCSL Phenocell C Reagent, 0.8%

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    14917
  • Event Initiated Date
    2013-07-01
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Seqirus Pty Ltd, 63 Poplar Road, Parkville, VIC 3052, AUSTRALIA
  • Reason
    The antigen composition sheet supplied with the product listed cell 5 as lua 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 did in fact type as lua positive.
  • Action
    Manufacturer to issue advice regarding use

Device

BioCSL Phenocell C Reagent, 0.8%
  • Model / Serial
    Model: Catalogue: 96530201, Affected: Lots: 9653052, 9653053, 9563054
  • Manufacturer
    Seqirus Pty Ltd

Manufacturer

Seqirus Pty Ltd