Events

Recall of EZ1 DSP Virus Kit (48). 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 Qiagen 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-2018-RN-00659-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00659-1
  • 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
    Qiagen have identified that the kit lots160017650, 160017770, and 160020069 contain a non-conforming ez1 dsp virus reagent cartridge lot (reg cart virus lot160011000). in the affected reagent cartridges, the proteinase k solution in well 10 is missing, i.E. well 10 is empty. at a maximum, eight of the 48 reagent cartridges in one kit are affected. all affected reagent cartridges are on position 6 within the clamshell box.
  • Action
    Qiagen is advising users to immediately discontinue use and dispose of kits with lots 160017650, 160017770, 160020069, and/or REAG CART LOT 160011000. Users should contact Qiagen technical service to arrange replacement.

Device

EZ1 DSP Virus Kit (48). An in vitro diagnostic medical device (IVD).
  • Model / Serial
    EZ1 DSP Virus Kit (48). An in vitro diagnostic medical device (IVD). Catalogue Number: 62724Lot Numbers: 160017650, 160017770 and 160020069 Corresponding Reagent Cartridge: REAG CART VIRUS (RCV)Reagent Cartridge Lot Number: 160011000ARTG Number: 211651(Qiagen Pty Ltd - General laboratory reagent and consumables IVDs)
  • Manufacturer
    Qiagen Pty Ltd

Manufacturer

Qiagen Pty Ltd