Events

Safety Alert for VITROS IMMUNODIAGNOSIS CALIBRATOR * FOR CA 19-9, registration 10132590514 and VITROS IMUNODIAGNOSTIC REAGENT KIT * FOR CA 19-9, registration 10132590488 - lots See Annex 1 - Distribution List

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
    1413
  • Date
    2014-07-28
  • 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
    As assessed by the manufacturer, this is a situation in which the use of or exposure to the affected product may lead to temporary or clinically reversible adverse health effects, or where the likelihood of serious adverse health consequences is remote.
  • Reason
    The company holding the registration informs that the product vitros® ca 19-9 reagent packs are used in vitros® eci / eciq immunodynamic systems, vitros® 3600 immunodiagnostic systems and vitros® 5600 integrated systems for the quantitative measurement of the defined antigen 1116-ns -19-9 in human serum and plasma. internal tests confirmed positive bias results generated with vitros® ca19-9, lot 1320. results from patient samples and proficiency samples showed positive bias in lot 1320 compared to previous batches.
  • Action
    The company directs customers to: i- Discontinue use immediately and discard all remaining inventory of CA19-9 Calibrators and Reagent Packs, Lot 1320, ii- Review previously reported results with VITROS® CA 19-9 Reagent Packs, Lot 1320, iii - Discuss with the Medical Director of the Laboratory or the requesting physician any questions you may have regarding previously reported results to determine the appropriate course of action. More information in the Letter to the Client - Annex II

Device

VITROS IMMUNODIAGNOSIS CALIBRATOR * FOR CA 19-9, registration 10132590514 and VITROS IMUNODIAGNOS...

Manufacturer

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