Events

Safety Alert for CHOLINESTERASE FS (COLINESTERASE FS) Technical Name: COLINESTERASE Registration Number ANVISA: 10350840138 Hazard Class: II Affected Model: R1: 5 x 20 mL / R2: 1 x 25 mL Serial Numbers Affected: 60109928

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by BIOSYS LTDA; DiaSys Diagnostic Systems GmbH.

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
    2130
  • Date
    2016-12-19
  • 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
    Customers / users who have purchased the batch related to this notification are directed to segregate all units of the product as nonconforming product and returned to our care, for later replacement by another suitable batch. It is further recommended that the results eventually measured with the quoted batch be checked using another batch number. #### Update of the field action: UPDATED ON 10/16/2017, the company presented the report of completion of the field action, with sending evidence of the collection and destruction of the affected products.
  • Reason
    Biosys ltda., the record holder of the referenced product, received a communication from the international manufacturer of the same, diasys diagnostic systems gmbh, stating that of the product colinesterase fs lot 60109928 had to be withdrawn from the market due to a failure in the packaging process of the product. reagent r2 and the units already marketed should be collected. due to failure of the r2 container both patient and control samples will show false low results or even an error report in the results to and process the enasio in automatic machines. biosys informs that it has not received a customer complaint related to the product in question.
  • Action
    Field Action Code 4130 triggered under the responsibility of the company BIOSYS LTDA. Company will collect for further destruction.

Device

CHOLINESTERASE FS (COLINESTERASE FS) Technical Name: COLINESTERASE Registration Number ANVISA: 10...

Manufacturer

BIOSYS LTDA; DiaSys Diagnostic Systems GmbH
  • Source
    ANVSANVISA