Events

Safety Alert for Product name: VITROS * DRY REACTIVE FOR SODIUM Technical Name: SODIUM ANVISA Registration Number: 10132590216 Hazard Class: II Affected Model: Box with 25 envelopes with 1 slide each / Box with 5 cartridges with 50 slides each Serial numbers affected: All VITROS Sodium Slides with SKU 8379034, generations 1 through 6, 30 through 40 and 44 through 49. Since this action affects all expired generations, in the validity and future generations, all customers with equipment compatible with the slides will be notified VITROS 250, VITROS 350, VITROS 5.1 FS, VITROS 4600 CHEMISTRY, VITROS 3600 IMMUNODIAGNOSTIC and VITROS 5600 INTEGRATED.

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
    2239
  • Date
    2017-03-20
  • 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
    Some instructions are recommended: • Until further notice, unopened VITROS Na + cartridges should be kept at room temperature, 18-28 ° C, prior to being loaded into the equipment for a minimum of 8 hours when stored frozen or refrigerated. • Recalibrate each VITROS System as soon as possible using a VITROS Na + cartridge that has been heated for a minimum of 8 hours. Failures to recalibrate can cause deviated results as described in Scenario 1. • As a precaution, when cartridges are available (after 8-24 hr warm-up) and recalibrated successfully on each VITROS System, remove and discard all cartridges VITROS Na + remaining stored in each equipment. • Place this notification next to each VITROS System that uses the VITROS Sodium products or along with your user documentation and complete and return the Receipt Confirmation NOTE: Until you are able to implement these instructions, you can continue to use the VITROS as long as the QC results are acceptable.
  • Reason
    Ortho clinical diagnostics (ortho) has identified potential deviation for reagent-generated results over the 10-day limit of use stability within the analyzer. this is associated with the use of vitros na + slides cartridges that were left at room temperature for between 1½ to 8 hours and were subsequently charged to the equipment. ortho has detected that the cartridges need to be left at room temperature for at least 8 hours before being loaded into the machine. this helps ensure that the slides will perform acceptable throughout the 10-day usage limit of the cartridges within the analyzer.
  • Action
    Field Action Code TC2016-226 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will update, correct or supplement the instructions for use.

Device

Product name: VITROS * DRY REACTIVE FOR SODIUM Technical Name: SODIUM ANVISA Registration Number:...

Manufacturer

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