Events

Safety Alert for VITROS IMMUNODIAGNOSTIC REAGENT KIT FOR B hCG TOTAL II - Registered in Anvisa under the number 80145901052 - Lots 0490 and 0530 - See attached list of Distribution (http://migre.me/5L5kp).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by JOHNSON & JOHNSON DO BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA SAÚDE LTDA.

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
    1092
  • Date
    2011-09-21
  • 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
    Ortho Clinical Diagnostics (OCD) has received complaints of observed results from diluted samples that were reported as <2.39 mIU / mL (IU / L) instead of No Result, which would be correct, and being accompanied by an Invalid Dilution - ID (Invalid Dilution). Action plan to be executed by the company (with schedule): - Register this notification in the database system for correct traceability of the case - Action taken on August 26, 2011 - Check which customers received the affected products and batches - Action held on August 26, 2011. - Communicate clients about what happened and guide the actions to be taken - Action started on September 9, 2011. - Obtain from the client the confirmation of receipt of the communication and actions taken. The letter signed by the client confirming receipt of the notification must be returned to the company by September 23, 2011. There are no records of notifications for this problem in Brazil, to date. Anvisa is following this action.
  • Reason
    Software failure that may affect the results of both the diluted samples manually and the samples diluted in the vitros eci / eciq immunodiagnostic system using the automated dilution feature and tested with the vitros immunodiagnostic reagent kits for β-hcg total ii, lots 0484 and 0530.
  • Action
    The following actions are required: Before reporting your lab results, review all results of the VITROS product for β-hCG Total II generated from samples that have been diluted and tested on the VITROS ECi / ECiQ System. Dilution results should be compared with pure (undiluted) results to identify discrepancies when using Batches 0484 and 0530. Place the VITROS Results Analysis Procedure for β-hCG Total II, next to the VITROS System ECi / ECiQ, to warn operators about this failure and assist them in reviewing the results of diluted samples. You should consult your Laboratory Medical Officer and requesting physician to resolve any questions you may have regarding previously reported results, including Batches 0484 and 0530 of the VITROS Reagent Kits for β-hCG Total II. Contact OCD Customer Technical Services to report adverse events that may be identified. Fill out and return to the record holder the Confirmation of Receipt form.

Device

VITROS IMMUNODIAGNOSTIC REAGENT KIT FOR B hCG TOTAL II - Registered in Anvisa under the number 80...

Manufacturer

JOHNSON & JOHNSON DO BRASIL INDÚSTRIA E COMÉRCIO DE PRODUTOS PARA SAÚDE LTDA