Events

Safety Alert for VITROS® Chemistry Products Calibrator Kit 9, Lot SKU 8568040 - 0954

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, Inc..

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
    1721
  • Date
    2015-10-27
  • 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
    The company informs that when condition code U90-382 or 6LU occurs, the VITROS® System hides the result and it is not reported. The increase in condition codes occurs mainly when using the VITROS® DGXN and PHYT Slides. All numerical results obtained are valid provided that no wash error has occurred and the quality control results are within acceptable limits.
  • Reason
    The manufacturer has identified a potential increase in condition codes u90-382 or 6lu (washing errors) when using the product vitros® calibrator kit 9, lot 0954.
  • Action
    The company is instructed to discontinue use of the product and discard all remaining inventory of VITROS® Calibrator Kit 9, Lot 0954 after receiving your replacement request. NOTE: It is acceptable to use Lot 0954 until your replacement request arrives. Recalibrate the VITROS® DGXN and PHYT Slides using the Cal Kit 9 in your installation, with an alternative batch of the calibrator, if available. Place this notification on each VITROS® System or along with the user documentation. Fill out and return the Receipt Confirmation Form. Further information: Annex I

Device

VITROS® Chemistry Products Calibrator Kit 9, Lot SKU 8568040 - 0954

Manufacturer

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