Events

Recall of MULTIGENT - AEROSET/C8000 HEMOGLOBIN A1C KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION.

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
    27085
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-08
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Whole blood samples (either fresh or frozen) for hba1c testing are pre-treated with multigent hemoglobin denaturant. the pre-treated samples are placed on the architect systems and tested for glycated hemoglobin (hba1c) and total hemoglobin (thb) concentrations. according to the package insert pretreated samples must be allowed to incubate for a minimum of 5 minutes at 15 to 30 degrees celcius prior to testing. pretreated samples are stated to be stable for "up to 8 hours at 15 to 30 degrees celcius and up to 48 hours if stored at 2 to 8 degrees celcius". however recent studies have demonstrated that hba1c measurements increase with time after the samples are pre-treated. therefore it is necessary to change the handling instructions for pre-treating samples for the multigent hba1c assay. the investigation to determine root cause is ongoing.

Device

MULTIGENT - AEROSET/C8000 HEMOGLOBIN A1C KIT
  • Model / Serial
    Model Catalog: 02K96-20 (Lot serial: 87689UN11); Model Catalog: 02K96-20 (Lot serial: 60580UN11); Model Catalog: 02K96-20 (Lot serial: 46731UN11); Model Catalog: 02K96-20 (Lot serial: 94681UN11)
  • Product Description
    MULTIGENT - AEROSET/C8000 HEMOGLOBIN A1C KIT
  • Manufacturer
    ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION

Manufacturer

ABBOTT LABORATORIES LIMITED. DIAGNOSTIC DIVISION
  • Manufacturer Address
    MISSISSAUGA
  • 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
    HC