Events

Safety Alert for Name of products: Immunodiagnostic reagent Vitros for Syphilis TPA, ANVISA Registry 80145901397. Classification IV. 7,400 affected units were imported by Brazil, of which 4,300 were distributed in the Brazilian market. Only one product code was affected (6842803), and the lots and distribution site 0514 (300 units in Belo Horizonte MG, 100 units in Tangará da Serra-MT, 2,900 units in Curitiba-PR, 100 units Campos dos Goytacazes-RJ and 100 units in São Gonçalo-RJ), 0515, 0520 (700 units in Campos dos Goytacazes-RJ and 100 units in Piracicaba), 0531

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho Clinical Diagnostics.

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
    1893
  • Date
    2016-05-09
  • 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
  • Reason
    Potential for inability to obtain a valid calibration when using vitros reagent kits for syphilis tpa, lots 0514, 0515, 0520 and 0531. ortho's investigation has confirmed that these batches of the vitros syphilis tpa reagent kit have met the warranty release specifications of quality. however, upon release, these batches exhibited a reduction in the reaction signal to the level of calibrator 1. initial tests indicate that the unexpected signal decrease is related to a specific batch of feedstock used in the manufacture of the product. as a result of this problem, you should discontinue use of the product and discard the affected lots.
  • Action
    Action code 16000062. Discontinue use and discard any remaining inventory of VITROS Reagent Kits for Syphilis TPA, Lots 0514, 0515, 0520 and 0531 and corresponding calibrators. (Manufacturer's Note: If the laboratory can successfully calibrate affected batches, and QA results are acceptable, the laboratory may continue to use the affected batches until it receives its replacement request.) Forward this notification if Kits have been provided of VITROS Reagent for Syphilis TPA, Lots 0514, 0515, 0520 and 0531 for other people outside your facility. Place this notification next to each VITROS® System that processes the VITROS Reagent Kits for Syphilis TPA.

Device

Name of products: Immunodiagnostic reagent Vitros for Syphilis TPA, ANVISA Registry 80145901397. ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho Clinical Diagnostics