Events

Safety Alert for CONTOUR TS Blood Glucose Test Strip - BAYER - Record 80384380008. CONTOUR TS BLOOD GLUCOSE TEST STRIPS - Schering - Registration 80146460011. Lots - As per attachment.

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

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
    1098
  • Date
    2011-10-25
  • 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
    Bayer states that it conducted extensive testing (described in the health risk assessment, modeling data and sensitivity analyzes) and determined that the problem potentially affects 25- and 10-strip flasks, but does not affect flasks with 50 units. It points out that, as documented in the health risk assessment, modeling data with sensitivity analyzes, and external expert review, Bayer is confident that the potential downward deviation of these products does not endanger the health of users. Bayer is evaluating corrective measures to definitively resolve the deviation issue down. As a consequence of the acquisition of Schering do Brasil, as well as the transfer of the records of the products to Bayer S / A, it informs the imported lots affected. Anvisa accompanies this action. #### UPDATE: 04/09/2012 - The company presents a validation report of the new packaging of reagent strips, which constitutes a permanent corrective measure for the problem indicated, through dossier 0714259 / 12-5. ####
  • Reason
    The company has identified that under certain conditions, certain test strips of the vials containing 5.10 or 25 units may operate outside the specified parameters and produce downward deviation reading during the blood glucose test.
  • Action
    As of September 22, 2011, to ensure the continuity of the supply of the Bayer product to consumers in Brazil, the Contour TS product (Test Kits and Strips) is being exchanged for the product Breeze 2 (Kits and Test Strip Disc ) that is not affected by the downward deviation problem. Consumers who have questions should contact Bayer Customer Service, calling toll-free 08007231010, for assistance and / or instructions on use and maintenance of the product.

Device

CONTOUR TS Blood Glucose Test Strip - BAYER - Record 80384380008. CONTOUR TS BLOOD GLUCOSE TEST S...

Manufacturer

BAYER S.A.
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    ANVSANVISA