Events

Recall of Device Recall EliA

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

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
    72969
  • Event Risk Class
    Class 2
  • Event Number
    Z-0697-2016
  • Event Initiated Date
    2015-12-28
  • Event Date Posted
    2016-01-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142606
  • 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
    Anti-sm antibody, antigen and control - Product Code LKP
  • Reason
    All equivocal and positive results (greater or equal 7 elia u/ml) on elia smdp well lot 0018 may be incorrect and must be considered invalid. patient samples in complaint investigations caused unspecific signals up to 22 u/ml on elia smdp well lot 0018. the nonspecific signals are not caused by anti-sm antibodies, nor by streptavidin antibodies.
  • Action
    On 12/28/2015, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions call 1-800-3464364, option #2.

Device

Device Recall EliA
  • Model / Serial
    Product number: 14-5624-01 Lot: 0018 Exp date: 11/30/2016
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.
  • Product Description
    EliA SmDP Well, Article Number 14-5624-01 || Product Usage: || EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.
  • Manufacturer
    Phadia Ab

Manufacturer

Phadia Ab
  • Manufacturer Address
    Phadia Ab, Rapsgatan 7, Rapsgatan Plant, Uppsala Sweden
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA