Events

Safety Alert for FAMILY ESTER, Brand: Biomerieux, Model: piperacillin / tazobactam - 30 and 100 strips (in blister pack); piperacillin / tazobactam - 30 and 100 strips (in foam cartridge). piperacillin / tazobactam - 30 individual strips (in single pack). Record: 10158120623, Reference 412431: Lots: 1004331500; 1004271120; 1003415090; 1003276060; 1003069230; 1002488490; 1001936360; Reference 521418 Lots: 1004276460; 1004180840; 1003980200; 1003416920; 1002995820; 1002482640; 1002375410; 1002276210; 1002092270

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Biomerieux Brasil S.A.; 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
    1768
  • Date
    2015-12-07
  • 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 risk to the patient, with the change in performance with Etest Piperacillin / Tazobactam, is the potential error in releasing incorrect results for this antibiotic, mainly in relation to false sensitivity. This risk can lead to medical intervention for the patient, because this incorrect result may negatively influence the choice of appropriate therapy.
  • Reason
    Reporting of low mic value. increased incorrect results, false sensitivity results, when compared with reference test (broth microdilution). an investigation has begun to confirm the performance of the product and to determine the root cause.
  • Action
    Collection, destruction of the product and blocking of marketing. The company will forward Letter to all customers who have purchased the product and instruct them to discontinue use and remove affected lots. The company will replace the kits. It is important to pass the alert to all the professionals of the laboratories that work with this product. Action code: 2709.

Device

FAMILY ESTER, Brand: Biomerieux, Model: piperacillin / tazobactam - 30 and 100 strips (in blister...

Manufacturer

Biomerieux Brasil S.A.; Biomerieux S.A.