Events

Safety Alert for ACID LACTIC Technical Name: Lactic Acid ANVISA Registration Number: 80146501641 Hazard Class: II Affected Model: Not applicable Serial Numbers Affected: 31497UN14; 09353UN15; 45216UN15; 14596UN15; 37055UN15 and 14782UN16

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 Laboratories Diagnostics Division..

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
    2161
  • Date
    2016-11-11
  • 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
    Please forward this notice to your Medical Director. Taking into account the above information, you may continue to use the ARCHITECT Lactic Acid reagent (LN 9D89-21). Complete and return the attached Customer Response Form. If you have forwarded the product listed above to other laboratories, please inform them of this Product Fix and provide a copy of this notice to the laboratory in question. Keep this statement in your lab files.
  • Reason
    Abbott identified negative interference of n-acetylcysteine ​​(nac) with the architect lactic acid reagent (ln 9d89-21). the table in the customer's release and annex describes the levels of interference observed at nac concentrations of 80 mg / l (0.49 mmol / l) and 800 mg / l (4.9 mmol / l).
  • Action
    Field Action Code FA10OCT2016 triggered under the responsibility of ABBOTT LABORATORIES DO BRASIL LTDA. Company will make correction in the field.

Device

ACID LACTIC Technical Name: Lactic Acid ANVISA Registration Number: 80146501641 Hazard Class: II ...

Manufacturer

Abbott Laboratórios do Brasil; Abbott Laboratories Diagnostics Division.
  • 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