Safety Alert for SEROLATEX PRODUCTS - CAT. 56 E 56K - LOTS 0018, 0019 AND 0020. PRODUCTS REUMALATEX PCR - CAT 54 AND 54K

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by LABTEST DIAGNOSTICA.

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
    38
  • Date
    2001-07-24
  • 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
    PROVIDES THAT THE PRODUCT HAS BEEN COLLECTED FROM THE MARKET SEROLATEX CATALOGOS 56 AND 56K, LOTS 0018, 0019 AND 0020, FOR THE PRESENTATION OF TECHNICAL PROBLEMS, EVEN IF THE PRODUCT WILL HAVE ITS MARKETING AND PRODUCTION DISCONTINUED UNTIL THE END OF DECEMBER 2001, THIS TIME TO TRY SOLVING THE PROBLEM. AND AS A PREVENTIVE MEASURE OPTION TO DISCONTINUE FOR THE SAME PERIOD, THE PRODUCTION AND MARKETING OF THE REUMALATEX PRODUCT CATÁLOGOS 54 AND 54K FOR USING A TECHNOLOGY SIMILAR TO SEROLATEX PCR.
  • Reason
    Technical problems occurring with the supplier's raw material.
  • Action
    LABTEST DIAGNOSTIC REPORTS THAT THE PRODUCT SEROLATEX CATALOGS 56 AND 56K, LOTS 0018, 0019 AND 0020, FOR THE PRESENTATION OF TECHNICAL PROBLEMS, HAS BEEN OBTAINED FROM THE MARKET, IT FURTHER INFORMES THAT THE PRODUCT WILL HAVE THE MARKETING AND PRODUCTION DISCONTINUED UNTIL THE END OF DECEMBER 2001, PERIOD THIS TO TRY TO SOLVE THE PROBLEM. AND AS A PREVENTIVE MEASURE OPTION TO DISCONTINUE FOR THE SAME PERIOD, THE PRODUCTION AND MARKETING OF THE REUMALATEX PRODUCT CATÁLOGOS 54 AND 54K FOR USING A TECHNOLOGY SIMILAR TO SEROLATEX PCR.

Manufacturer

  • Source
    ANVSANVISA