Events

Recall of CELL-DYN Emerald Cleaner. 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 Abbott Australasia Pty Ltd Diagnostic Division.

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-00388-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00388-1
  • 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
    Abbott has identified occurrences where the cell-dyn emerald analyser generates quality control (qc) out of range low for parameters rbc and plt. abbott is continuing to investigate but immediate actions by the laboratory are necessary. abbott has no evidence that there is impact to generated patient results. there is a potential for delay in results due to qc out of range.
  • Action
    Abbott is advising users to switch to an alternative lot of Cleaner reagent if available, and destroy any remaining inventory of the affected lots. If users are not experiencing the error and do not have an alternative lot to use, please order a replacement and continue to use the reagent provided internal QC results remain in specification. Users are advised to contact customer support if they are experiencing the error and do not have an alternative lot available. This action has been closed-out on 26/05/2017.

Device

CELL-DYN Emerald Cleaner. An in vitro diagnostic medical device (IVD)
  • Model / Serial
    CELL-DYN Emerald Cleaner. An in vitro diagnostic medical device (IVD)List number: 09H46-02Lot numbers: 6853, 6901Expiry date: 31 July 2017Lot number: 6953Expiry date: 30 Sep 2017Lot Numbers: 6991Expiry date: 30 Nov 2017Lot Numbers: 7024, 7027Expiry date: 31 Dec 2017Lot Number: 7044Expiry date: 31 Jan 2018Lot Number: 7082Expiry date: 28 Feb 2018Lot Number: 7110Expiry date: 31 Mar 2018Lot Number: 7119Expiry date:30 Apr 2018ARTG number: 225068
  • Manufacturer
    Abbott Australasia Pty Ltd Diagnostic Division

Manufacturer

Abbott Australasia Pty Ltd Diagnostic Division
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA