Events

Safety Alert for ATB - DENSITOMETER CONTROL DEVICE, Mark: Biomerieux, Registration: 10158120674, lots 1003780430, 1003838260, 1003848040, 1003883560, 1003990940, 1004089920.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Biomerieux Brasil SA.; Biomerieux 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
    1746
  • Date
    2015-11-12
  • 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
    According to the company the problem may cause a failure to control the calibration of the Densimat instrument, potentially leading to false susceptibility or false identification results. ### Update of the field action: UPDATED ON 07/28/2017, the company presented the completion report of the field action proving the sending of the safety notice to the client and destination of the nonconforming products.
  • Reason
    Performance failure, with change in performance, in the lots described for the product atb- densitometer control device. in this case, the calibration check of the densimat equipment may fail.
  • Action
    The company will collect and destroy the products. A letter will be forwarded to all customers who have purchased the affected lots, with detailed guidance on how to proceed with the product covered by this field action. The company directs you to stop using the affected product and fill out the Notification form to notify the company of any remaining stock of the kit. The company's recommendation is that until the manufacturing of new lots, the Mc Farland standard scale can be used as a back-up solution. A new batch of the product was released to replace the nonconforming product. Additional batches will be available for allocation until the breach situation is resolved. As soon as stock is normalized, bioMérieux will contact customers.

Device

ATB - DENSITOMETER CONTROL DEVICE, Mark: Biomerieux, Registration: 10158120674, lots 1003780430, ...

Manufacturer

Biomerieux Brasil SA.; Biomerieux S. A