Safety Alert for Name of products: Calibrator Kit 29 Vitros *, RegANVISA 80145900910. Product classified as II and the control of these systems is carried out by lot number. 89 units of the reagent kit were imported. Product code 6802344, Lots affected and imported into Brazil: 2915, 2995

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
    1945
  • Date
    2016-07-12
  • Event Country
  • Event Source
    ANVISA
  • Event Source URL
  • 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
    If you have any questions regarding this field action, please contact Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. by telephone: 12 3932-7977 or e-mail: gbuosi@its.jnj.com Recommendations to users: Action required for laboratories that have the affected lot: • As soon as available, install ADD DRV 5884 or later on your system VITROS. o Connected Systems: Automatic download will be available in early May 2016. o ADD DRV 5884 or later will also be sent to your facility upon availability. NOTE: After loading ADD DRV 5884 or later for the first time, the VITROS dTIBC GEN 30 Reagent will lose the calibration and must be recalibrated. • After successful calibration and quality control evaluation, it is acceptable to use your remaining inventory of the VITROS dTIBC, GEN 30 Reagent. • Place this notification on your VITROS System or along with your user documentation. • Complete and return the Receipt Confirmation form
  • Reason
    The manufacturer has detected that there are incorrect values ​​(data / calibration math) on assay data diskettes (add) for calibrator kit 29, which supports the vitros dtibc, gen 30 reagent. incorrect values ​​will cause a positive trend in the sample results (ie, patient samples, proficiency fluids, and quality control fluids).
  • Action
    Action code 16000095. Sending of the Letter to the Clients // Recommendations to the users.