Events

Recall of Device Recall IMx HAVAB Controls

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Health Products, 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
    31342
  • Event Risk Class
    Class 3
  • Event Number
    Z-0660-05
  • Event Initiated Date
    2005-03-04
  • Event Date Posted
    2005-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37698
  • 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 (Antibody And Igm Antibody) - Product Code LOL
  • Reason
    Abbott identified through investigational studies that imxhavab controls lot 21059q100 is generating negative control values outside the upper range specified in the imxhavab package insert.
  • Action
    Abbott identified through investigational studies that IMx HAVAB Controls lot 21059Q100 is generating Negative Control values outside the upper range specified in the IMx HAVAB Package insert. If a control value is out of the specified range, the assay run is invalid and assay recalibration may be indicated. If the control values are within range as specified in the package insert, the assay run is valid and the patient results are not impacted.

Device

Device Recall IMx HAVAB Controls
  • Model / Serial
    Lot # 21059Q100 Expiration Date: May 20, 2005
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled IMx HAVAB Controls were distributed nationwide in the United Stated, including Puerto Rico and internationally were distributed to Canada, Peru, Germany, Japan, Australia, and Singapore. There are US Government accounts.
  • Product Description
    IMx HAVAB Controls In Vitro Test
  • Manufacturer
    Abbott Health Products, Inc.

Manufacturer

Abbott Health Products, Inc.
  • Manufacturer Address
    Abbott Health Products, Inc., Hwy 2 Km 58.0, Barceloneta PR 00617
  • Source
    USFDA