Events

Recall of PHADIA VarelisA Cardiolipin IgM Antibodies Assay

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

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
    62572
  • Event Risk Class
    Class 3
  • Event Number
    Z-2285-2012
  • Event Initiated Date
    2012-08-02
  • Event Date Posted
    2012-08-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111072
  • 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
    in vitro diagnostic - Product Code MID
  • Reason
    Customers were not following the labeled assay procedure. this was due to a letter issued to them in 2004 from phadia gmbh, which indicated that customers could omit the pre-wash step. the omission of the pre-wash step, when combined with a change in material source in kit lot #0067, caused elevated results.
  • Action
    On 8/2/2012 an URGENT PRODUCT CORRECTION INFORMATION FOR PHADIA VARELISA CARDIOLIPIN IGM, Article Number 15696 letter was sent to all consignees the received the Direction for Use modification letter in 2004.

Device

PHADIA VarelisA Cardiolipin IgM Antibodies Assay
  • Model / Serial
    Article Number 15696 Lot number #0067
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide.
  • Product Description
    PHADIA Varelisa Cardiolipin IgM || Cardiolipin autoantibody immunological test system (IgM class antibodies)
  • Manufacturer
    Phadia US Inc

Manufacturer

Phadia US Inc
  • Manufacturer Address
    Phadia US Inc, 4169 Commercial Ave, Portage MI 49002-9701
  • Manufacturer Parent Company (2017)
    Fsii Sweden Holdings I Ab
  • Source
    USFDA