Events

Recall of AxSYM total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent.

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
    31586
  • Event Risk Class
    Class 3
  • Event Number
    Z-0893-05
  • Event Initiated Date
    2005-03-24
  • Event Date Posted
    2005-06-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38201
  • 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
    Visual, Pregnancy Hcg, Prescription Use - Product Code JHI
  • Reason
    Abbott diagnostics is investigation a recent increase in customer complaints for axsym calibration error code 1048 and controls out of range when using axsym total b-hcg reagent lots. testing has shown that protein aggregates are present in the specimen diluents of both imx and the axsym total b-hcg reagent kits. this is responsible for the calibration errors and shift in control values.
  • Action
    Abbot Health Products, Inc. informed and instructed their customers via Device Recall Letter to Identify if they have used or have inventory of the affected product. Discontinue use of and destroy any remaining inventory of reagent lots listed in the Device Recall letter according to their laboratory procedures. Record the quantity of the recalled reagents currently in inventory in their facility that will be destroyed on the attached reply form and fax the form back to Abbott 1-800-777-0051. (US only) Follow their laboratory''s procedure for communicating this issue to the health care providers they serve.

Device

AxSYM total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkal...
  • Model / Serial
    2614Q100 (5/13/2005);  26278Q100, 26381Q100 (6/21/2005)
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic , US Goverment and International ditribution.
  • Product Description
    AxSYM total B-hCG Reagent is composed of one bottle of Coated Microparticles, one bottle of Alkaline Phosphatase Conjugate and one bottle of Specimen Diluent.
  • 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