Events

Safety Alert for Coagulation Parameters - Models: ACL TOP, ACL TOP CTS, ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS. ANVISA Registry No. 80003610138

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

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
    1401
  • Date
    2014-07-01
  • 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
    Access letter NOTIFICATION OF FIELD ACTION. Email: http://portal.anvisa.gov.br/wps/wcm/connect/abdfc98044d9494d871697b0e5034f2e/Carta+Seguran%C3%A7a+Werfen.pdf?MOD=AJPERES
  • Reason
    Potential for non-sample identification error in acl top family equipment, occurring only after a specific set of actions combined with the inability of the system to read a bar code from the rack of a specific sample.
  • Action
    Issuance of a letter of safety to distributors and customers with instructions to prevent occurrences of sample identification error. In July / 2015 the company announced the continuation of this field action that corresponds to the importation of software to update the equipment.

Device

Coagulation Parameters - Models: ACL TOP, ACL TOP CTS, ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 ...

Manufacturer

Instrumentation Laboratory
  • Source
    ANVSANVISA