Events

Recall of Abbott Laboratories HbA1c Calibrators

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
    68201
  • Event Risk Class
    Class 2
  • Event Number
    Z-0135-2015
  • Event Initiated Date
    2014-04-30
  • Event Date Posted
    2014-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129681
  • 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
    Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
  • Reason
    Hba1c calibrators ln 4p52-02, lot 45063uq12 may contain a value sheet for a different hba1c calibrator lot. if calibrator lot 45063uq12 is used in the calibration of the hba1c assay using values from an incorrect calibrator value sheet then all results, including quality control and patient, may be falsely elevated.
  • Action
    Product Correction letters dated April 30, 2014 were sent to all customers. The letters included isntructions for customers to: 1) verify that the lot numbr listed on each calibrator bottle agrees with the lot number printed on the value sheet; 2) If HbA1c Calibrators lot 45063UQ12 has already been utilized in your laboratory, verify the concentrations configured for this calibrator lot match the values in the letter; 3) If these do not match, use the values in the letter when calibrating the HbA1c assay using calibrator lot 45063UQ12; and, 4) follow your laboratory protocol regarding the need for reviewing previously reported patient results if incorrect calibrator values were used.

Device

Abbott Laboratories HbA1c Calibrators
  • Model / Serial
    List Number: 4P52-02;  Lot Number: 45063UQ12;  Expiration Date: 15 DEC 2014
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution in the countries of Austria, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, Kuwait, Malaysia, Norway, Poland, Romania, Russia, Saudi Arabia, Thailand, Turkey, and United Arab Emirates.
  • Product Description
    HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. || For use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems.
  • 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