Events

Safety Alert for Commercial Name: ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. ANVISA Registration Number: 80146501834 .. Hazard Class: III. Lots: attached list .. Lot lot affected: 2.555 units .. Number of units distributed: 1.980.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATÓRIOS DO BRASIL LTDA; Abbott Ireland 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
    2023
  • Date
    2016-07-04
  • 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
    According to company information: Ask your laboratory to take the Required Measures below to reduce the possibility of incidences of calibration errors. A. Once alternative batch is available, return any remaining stock from the following lots of ARCHITECT STAT High Sensitive Troponin-I reagents. (List not attached notice). B. If your laboratory DOES NOT have a batch of alternative reagent available in stock and has generated a valid calibration curve, immediately request the reagent batch replenishment. Continue to use these batches and follow the QC procedures recommended in the instructions for use. These lots have high potential for calibration failures with continued use. If calibration failures are repeated, they will prevent your lab from generating patient results. Once the replacement reagent lot is received, return any remaining stock from the reagent lots according to your laboratory procedures. C. If your laboratory has a batch of available alternate reagent in stock, continue to use these reagents immediately and begin using the alternate reagent batch. Return any remaining stock of batches of reagents according to your laboratory procedures. Your local Abbott representative can assist you in providing replacement products, financial credit and / or recommended alternative solutions. All future lots will have an appropriate shelf life before delivery. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link
  • Reason
    Field action on reducing the shelf life of selected batches of architect stat high sensitive troponin-i reagents listed in table 1 of the customer release. predictive monitoring of quality assurance of architect stat high sensitive troponin-i reagent lots was initiated after the field action in january - ref .: fa21jan2016 (field action not applicable to brazil for not having a lot distributed in brazil). as a result, abbott has identified a potential for increased calibration failures before the expiration date. the root cause of this situation is under investigation for appropriate long-term corrective action.
  • Action
    Field Action No. FA21JAN2016 Revision 02, triggered under the responsibility of Abott. Classification of risk: III Classification of the field action: Field action - Change of validity d)

Device

Commercial Name: ARCHITECT STAT High Sensitive Troponin-I Reagent Kit. ANVISA Registration Number...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA; Abbott Ireland 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