Events

Safety Alert for A: CLINICAL CHEMISTRY SYSTEMS WITH SOFTWARE VERSIONS LESS THAN 7.0: (1) MODEL 3332 VITROS 250, (2) MODEL 3391 VITROS 250 AT; B: CLINICAL CHEMISTRY SYSTEMS WITH SOFTWARE VERSIONS LESS THAN 3.07: (3) MODEL 3360 VITROS 950, (4) MODEL 3361 VITROS 950 AT

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ORTHO-CLINICAL DIAGNOSTICS INC A JOHNSON & JOHNSON CO..

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
    20
  • Date
    2001-05-14
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The results of non-conjugated bilirubin can result less than 0.0 mg / dl or the results of the conjugated bilirubin can not sign the potential interference codes when a spectral interference is existed in a sample of the patient. the problem.
  • Action
    VERIFY THAT YOU HAVE RECEIVED THE LETTER OF OCTOBER 6, 2000 FROM ORTHO-CLINICAL DIAGNOSTICS INC. TO JOHNSON & JOHNSON CO. . IDENTIFY THESE SYSTEMS THAT MAY BE WITH AFFECTED VERSIONS IN YOUR INVENTORY. ORTHO-CLINICAL DIAGNOSTICS AFFIRMS THAT VERSION 7.0 OR MORE FOR THE SITEMAS VITROS 250 OR 250 AT CORRECTED THE PROBLEM. SOFTWARE TO CORRECT THE PROBLEM WITH 950 AND 950 VOTES AT STILL NOT AVAILABLE. IF REPORTS OF NON-CONJUGATED BILIRUBIN AND CONJUGATED BILIRUBIN ARE REQUIRED, ORTHO-CLINICAL DIAGNOSTICS RECOMMENDS THE FOLLOWING: (1) REVIEW ALL REPORTS OF RESULTS OF NON-CONJUGATED BILIRUBIN AND CONJUGATED BILIRUBIN; (2) IF THE RESULTS OF NON-CONJUGATED BILIRUBIN ARE LOWER THAN THE ANALYZER INTERVAL, DO NOT REPORT THE CORRESPONDING CONJUGATED BILIRUBIN RESULT. (3) DO NOT USE THE PRINTED MONITOR RESULTS TO REPORT RESULTS OF UNLESS CONNECTED BILIRUBIN ANALYSIS. FOR FURTHER INFORMATION CONTACT YOUR LOCAL REPRESENTATIVE OF ORTHO-CLINICAL DIAGNOSTICS.

Device

A: CLINICAL CHEMISTRY SYSTEMS WITH SOFTWARE VERSIONS LESS THAN 7.0: (1) MODEL 3332 VITROS 250, (2...

Manufacturer

ORTHO-CLINICAL DIAGNOSTICS INC A JOHNSON & JOHNSON CO.