Events

Safety Alert for ARCHITECT TESTOSTERONE - Records 80146501466, 80146501467, 80146501468. Affected Lots - 11907JN01, 13909JN01, 15909JN01, 15916JN00, 1897JN01, 18907JN02, 201901JN01, 11907JN00, 13909JN00, 15909JN00, 15916JN01, 18907JN00, 21901JN03, 21901JN04, 17342JN00, 19142JN00, 19142JN01, 19142JN02, 22270JN00 , 23277JN00, 23277JN01, 17203JN00, 19075JN00, 22121JN00 and 23199JN00.

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.

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
    1222
  • Date
    2013-01-15
  • 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
    Exposure to materials containing Methylisothiazolones may cause an allergic skin reaction. Personal protective equipment should be used in accordance with your laboratory practice to ensure adequate protection against such an event. This warning is not a result of any adverse events reported in relation to the product marketed. Anvisa follows this Field Action. #### UPDATE - 04/29/2013 - CLOSURE of the action communicated by the company.
  • Reason
    The current architect testosterone reagents, calibrators and controls labels do not contain warnings and precautions applicable to materials containing methyl-isotiazolones, classified as skin sensitizers.
  • Action
    The company recommends to professionals users: 1) Treat this product as skin sensitizer. 2) If you have forwarded the products listed in the List of Affected Lots list distributed in Brazil to other laboratories, please provide a copy of this notice to the laboratory in question. 3) Keep a copy of this notice for future reference. 4) The instructions for use shall be corrected from the following lots: ARCHITECT Reagents Testosterone, from lot 24900UI01 - Reagents ARCHITECT Testosterone, from lot 24900UI00 - ARCHITECT Testosterone Calibrators, from lot 24912UI00 - Controls ARCHITECT Testosterone, from from lot 24911UI00

Device

ARCHITECT TESTOSTERONE - Records 80146501466, 80146501467, 80146501468. Affected Lots - 11907JN01...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA
  • Source
    ANVSANVISA