Events

Recall of Device Recall ARCHITECT HAVABM Reagent

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Diagnostics International, Ltd..

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
    55165
  • Event Risk Class
    Class 2
  • Event Number
    Z-1596-2010
  • Event Initiated Date
    2009-12-30
  • Event Date Posted
    2010-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90201
  • 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
    Hepatitis A Test - Product Code LOL
  • Reason
    There is a potential to generate a false grayzone or reactive havab-m result when the architect ausab assay precedes the architect havab-m assay.
  • Action
    Direct accounts (hospitals, private laboratories, and other institutions) were sent a Product Correction letter, dated 12/30/2009. The letter identified the affected product, explained the issue and patient impact, and listed several necessary actions. Customers were instructed to follow one of 4 different alternatives to protect the integrity of test results. The letter is to be retained for laboratory records and a copy should be sent to other laboratories that kits were forwarded to. Questions regarding this information should be directed to Customer Service at 1-877-4ABBOTT.

Device

Device Recall ARCHITECT HAVABM Reagent
  • Model / Serial
    Lot # 76175Q100 exp. date 4/18/10; Lot # 79412Q100 exp. date 7/22/10; Lot # 82584Q100 exp. date 10/20/10.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- Including Puerto Rico.
  • Product Description
    ARCHITECT HAVAB-M Reagent || A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum.
  • Manufacturer
    Abbott Diagnostics International, Ltd.

Manufacturer

Abbott Diagnostics International, Ltd.
  • Manufacturer Address
    Abbott Diagnostics International, Ltd., Carr # 2 Km 58.0, Cruce Davila, Barceloneta PR 00617
  • 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