Events

Safety Alert for REAGENT KIT hsCRP VITROS, Model HsCRP Reagent Kit Cx 6 / 50T - Registro 80145900837 - Lote 28-3487

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.

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
    1391
  • Date
    2014-05-14
  • 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
    The company informs that European Reference Material (ERM) is a calibration reference standard used to support the assigned value of the calibrator kit VITROS® 17 and VITROS® FS Calibrator 1. Both calibrators are used together to calibrate the calibration systems. VITROS® 5,1 FS, VITROS®4600 and VITROS®5600 integrated systems for quantitative measurement of Reactive Protein C (CRP) using the VITROS hsCRP reagent. CRP is used to assess the risk of developing coronary heart disease (CHD). The risk of coronary heart disease increases with CRP values ​​greater than 3 mg / L. The client should discuss any concerns they may have about the results reported previously with their medical director or the requesting physician. The results from this or any other diagnostic test should be used and interpreted only in the context of the entire clinical picture #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the field action at any time.
  • Reason
    This product correction was initiated because the calibrator values ​​assigned to the batches of listed calibrator kits were released through a reference method, which was subjected to validation of a new batch of european reference material (erm). the validation process was not completed before the calibrator value for vitros ® hscrp reagent (product code 6801739), generation (gen) 28. the manufacturer identified this event internally, and there were no reports of customer complaints related to the subject.
  • Action
    The company urges customers to - Immediately discontinue use of the VITROS hsCRP, GEN28 reagent until the installation of ADD 5784 or above. - Install ADD 5784 on your VITROS® System as soon as you receive it. After a successful recalibration, the remaining VITROS ® hsCRP, GEN 28 Reagent in the inventory may be used

Device

REAGENT KIT hsCRP VITROS, Model HsCRP Reagent Kit Cx 6 / 50T - Registro 80145900837 - Lote 28-3487

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda