Events

Recall of Device Recall AxSYM AUSAB Reagent Pack

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

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
    45395
  • Event Risk Class
    Class 2
  • Event Number
    Z-0127-2008
  • Event Initiated Date
    2007-10-01
  • Event Date Posted
    2008-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65373
  • 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 B Test - Product Code LOM
  • Reason
    Incorrect results: reagents in these lots were manufactured with an incorrect ratio of 2 key components, which could result in both false reactive and false nonreactive specimens.
  • Action
    Abbott sent a Product Recall letter, dated 10/01/07, to all AxSYM AUSAB customers that received the affected lots of product, informing them of the manufacturing error that resulted in both false reactive and false nonreactive specimens. The letter provided the assay bias for both lots. The accounts were requested to examine their inventory for the affected lots; destroy any packs found; record the number of packs destroyed on the Customer Reply Form; and fax the completed form back to Abbott at 1-800-777-0051 prior to 10/12/07. They were also requested to evaluate patient results generated with these lots in alignment with the information provided in the letter to determine if additional action is necessary. They were requested to forward a copy of the letter to any laboratory to whom they may have forwarded the lots; and to retain a copy of the letter for their records. Any questions were directed to Abbott Customer Support at 1-877-4ABBOTT.

Device

Device Recall AxSYM AUSAB Reagent Pack
  • Model / Serial
    Lot Numbers: 49535M100 and 55451M200
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution, including Puerto Rico.
  • Product Description
    Abbott AxSYM AUSAB Reagent Pack, List No: 3C74-20, 100 tests, an in-vitro test for Antibody to Hepatitis B Surface Antigen (Anti-HBs); Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • Manufacturer Address
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • 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