Events

Safety Alert for ICT CALIBRATOR (Registro Anvisa: 10055310936).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATORIES.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    904
  • Date
    2008-03-24
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    Abbott Laboratories of Brazil Ltda reported that it has already communicated 100% of the clients who received lot 0505017 of the ICT Calibrator, through informative letters. If you need to inform the company about this problem, you must use the Customer Service Center at 0800-11-9099 (use FA26SEP2007). The Technovigilance unit is following up on this case.
  • Reason
    The ict calibrator product, lot no. 0505017, may contain an interferer that affects the reading of the potassium element (k +), which may generate an acceptable but low slope calibration curve.
  • Action
    Abbott asks the user to review his stock and identify the vials of the Clinical Chemistry ICT Calibrator, lot number 0505017. If the ICT Calibrator Lot 0505017 is being used or is identified in stock, it is important to follow the following instructions : (1) If calibration with batch No. Calibrator No. 0505017 generates an acceptable slope for K + and the calibration is within the acceptable QC range of the test, then the K + calibration is acceptable and the vial 0505017 can be used until a new batch number is available in the user's lab. Once a new batch is received, the user must recalibrate the K + assay with the new batch of the calibrator, separate and send all remaining kits from lot 0505017 to ABBOTT. (2) If the calibration with batch Calibrator batch No. 0505017 generates an acceptable slope for K + and the calibration is below the acceptable QC range of the test, then the K + calibration is not acceptable and batch vial 0505017 should not be used for testing.

Device

ICT CALIBRATOR (Registro Anvisa: 10055310936).

Manufacturer

ABBOTT LABORATORIES
  • 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
    ANVSANVISA