Events

Safety Alert for I-STAT KAOLIN ACT CARTRIDGE Technical Name: ACTIVATED COAGULATION TIME ANVISA Registration Number: 80146501500 Hazard Class: III Affected Model: Not applicable Serial Numbers Affected: Customers using software version JAMS142E.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Abbott Laboratórios do Brasil; Abbott Point of Care Inc..

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
    2228
  • Date
    2017-03-17
  • 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
    Our records show that your installation is testing the i-STAT Celite ACT or Kaolin ACT cartridges. APOC recommends upgrading all i-STAT analyzers running the Celite ACT or Kaolin ACT test with the JAMS142G software version. This notice only affects the operation of Celite ACT or Kaolin ACT cartridges cartridges. There is no impact on other analytes. Follow the instructions included in this communication for installing the software from the included software disc or the Abbott Point of Care website. Https://www.pointofcare.abbott/us/en/offerings/support/software-license-keys/istat-system-software-update. Fill out and return the customer's response letter to acknowledge receipt of this communication and installation of the software. If you have forwarded the cartridges to another facility, provide a copy of this notice.
  • Reason
    Abbott point of care inc. (apoc) has determined that celite act and kaolin act cartridges can produce falsely low results when very high samples of coagulation time are tested. patient samples with a coagulation time measured> 853 seconds for celite and> 1134 seconds for kaolin may show results of approximately 100 to 200 seconds while using the jams142e software version. the typical therapeutic range of the i-stat act assay is 200 to 600 seconds.
  • Action
    Field Action Code APOC2017-001 triggered under the responsibility of the company Abbott Laboratórios do Brasil LTDA. Company will make correction in the field.

Device

I-STAT KAOLIN ACT CARTRIDGE Technical Name: ACTIVATED COAGULATION TIME ANVISA Registration Number...

Manufacturer

Abbott Laboratórios do Brasil; Abbott Point of Care Inc.
  • 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