Events

Recall of DIASTAT antiNuclear Antibody (ANA)/DIASTAT ANA ELISA

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Euro Diagnostica 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
    79183
  • Event Risk Class
    Class 2
  • Event Number
    Z-0929-2018
  • Event Initiated Date
    2015-10-15
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161552
  • 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
    Antinuclear antibody, antigen, control - Product Code LKJ
  • Reason
    Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the elisa plate, the strong igm conjugate, and the low reference control led to an increased risk of equivocal and/or false positive sample test results for the two fana200 kit lots ss 1500 and ss 2009.
  • Action
    Euro Diagnostica sent a Customer notifications letter to affected customers via email on 10/15/2015. The letter identified the affected product problem and actions to be taken. For question contact Euro Diagnostica .

Device

DIASTAT antiNuclear Antibody (ANA)/DIASTAT ANA ELISA
  • Model / Serial
    UDI: 07340058410486. Lot numbers: SS 1500 and SS 2009.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution and US. Nationwide
  • Product Description
    DIASTAT anti-Nuclear antibody (ANA) / DIASTAT ANA ELISA. Catalog Number: FANA200. || Product Usage: || The DIASTAT¿ anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl- 70, Jo-1, dsDNA, histone and centromere antigens.The test may be used to screen out samples which are negative for all ANAs. Samples that give a positive test result should be further tested to identify the antigen-specific antibody or antibodies present. Quantitative/qualitative ELISA kits are available for the individual detection of Sm, Sm/RNP, Ro (SS-A), La (SS-B), dsDNA and centromere ANAs. Qualitative kits are available for the individual detection of Scl-70 and Jo-1. ANA detection represents one parameter in a multicriterion diagnostic process.
  • Manufacturer
    Euro Diagnostica AB

Manufacturer

Euro Diagnostica AB
  • Manufacturer Address
    Euro Diagnostica AB, Box 50117, Lundavagen 151, Malmo Sweden
  • Manufacturer Parent Company (2017)
    C&P Investors Limited
  • Source
    USFDA