Events

Safety Alert for TOTAL PROTEIN - Record in Anvisa - 80115310073 - Lots Affected: 1073671330/1073671229/1073661354/1073661352/1073661353/1085501210/1085501211/1073661249/1073671227/1073661251/1085501313/1073671228.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by KOVALENT DO BRASIL 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
    1238
  • Date
    2013-04-02
  • 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 loss of stability in the on-board situation is being investigated. Additional control measures will be defined. The risk of releasing incorrect results is considered medium to high if the instructions for use of the product are not followed. As the instructions for use are emphatic regarding the need for use of controls during the procedure, the remaining probability of incorrect results becomes low and the risk tolerable. The controls used will detect the need for re-calibration of the test before releasing the final results. In the manual procedure this loss of stability is not observed since, after use, the reagent bottles are capped and returned to the storage informed in the Instructions for Use.
  • Reason
    Loss of stability of the reagents after a few hours when in the "on board" situation, ie when left inside the rotor of automated equipment.
  • Action
    The company recommends that the use of the products be stopped immediately. Verify in your inventory the existence of the lot of the affected product, segregating it and returning it or destroying it, according to the institution's procedures and those recommended by the manufacturer.

Device

TOTAL PROTEIN - Record in Anvisa - 80115310073 - Lots Affected: 1073671330/1073671229/1073661354/...

Manufacturer

KOVALENT DO BRASIL LTDA