Events

Recall of Device Recall ARCHITECT HBsAg Qualitative Assay, ARCHITECT HBsAg Qualitative Confirmatory Assay

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories, 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
    63946
  • Event Risk Class
    Class 2
  • Event Number
    Z-0987-2013
  • Event Initiated Date
    2012-12-18
  • Event Date Posted
    2013-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115090
  • 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
    Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
  • Reason
    Abbott has identified that assay files for the architect hbsag qualitative and hbsag qualitative confirmatory assays (lns 4p53 and 4p54) on the architect i1000sr system were mistakenly made available on abbottdiagnostics.Com in october 2012. additionally, some i1000sr customers received notification through abbottlink in november 2012 that assay files for lns 4p53 and 4p54 were available. the ar.
  • Action
    The firm decided to correct the issue and and sent out Urgent Field Safety Notices to their customers dated 10/18/2012.

Device

Device Recall ARCHITECT HBsAg Qualitative Assay, ARCHITECT HBsAg Qualitative Confirmatory Assay
  • Model / Serial
    All shipped out to this date
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.
  • Product Description
    ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54 || The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum.
  • Manufacturer
    Abbott Laboratories, Inc

Manufacturer

Abbott Laboratories, Inc
  • Manufacturer Address
    Abbott Laboratories, Inc, 1921 Hurd Dr, Irving TX 75038-4313
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA