Events

Recall of Device Recall QIAamp DSP Virus Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Qiagen, GmbH.

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
    78646
  • Event Risk Class
    Class 2
  • Event Number
    Z-0274-2018
  • Event Initiated Date
    2017-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160061
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    unknown device name - Product Code N/A
  • Reason
    Certain lots of the qiaamp dsp virus kit, ref 60704, used in analytic workflows could result in decreased performance.
  • Action
    Qiagen sent ffected customers and commercial partners "Urgent Notice of Product Field Action", dated June 22, 2017 via an e-mail containing a letter as pdf. In the letter, customers were informed of the reason for recall, with an overview of affected products, detailed description of issue, consequences of the issue, actions to be taken by the customer/user, completion of the acknowledgement of receipt form, contact information and the commercial partners are instructed to forward , actions that have been initiated by AIAGEN, the letter to their customers.

Device

Device Recall QIAamp DSP Virus Kit
  • Model / Serial
    QIAamp DSP Virus Kit, Cat. No. 60704, lot 154025928 , 154027751, 154029053, 154029743 and 154029744.
  • Distribution
    AR; AT; BE; CH; CN; CZ; DE; ES; FR; GB; GR; HK; IN; IR, IT; KR; MX; NL; NP, PH; PK; PL; TR, TW; US; UY, VN
  • Product Description
    QIAamp DSP Virus Kit || Cat. No. 60704
  • Manufacturer
    Qiagen, GmbH

Manufacturer

Qiagen, GmbH
  • Manufacturer Address
    Qiagen, GmbH, Qiagen Str. 1, Hilden Germany
  • Manufacturer Parent Company (2017)
    QIAGEN N.V.
  • Source
    USFDA