Events

Safety Alert for ETEST FAMILY - CEFOTAXIME - 100TIRAS, REGISTRATION 10158120623, CLASS OF RISK II, LOT 1002377890 (VALID 06/06/2015)

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
    1648
  • Date
    2015-07-24
  • 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, Quality Control has failed because a strain expected to be susceptible to the antibiotic appears to be resistant. ### 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
    Internal failure in quality control. identified a deviation of performance associated with the quality control test from retained product samples, resulting in results outside the specification of resistant strains.
  • Action
    The company will not send the letter to the customer once the unit of the batch marketed, at the time of the investigation, had its expiration date. If the customer has performed quality control tests and presented result accordingly, the strips can be considered safe.

Device

ETEST FAMILY - CEFOTAXIME - 100TIRAS, REGISTRATION 10158120623, CLASS OF RISK II, LOT 1002377890 ...

Manufacturer

Biomerieux Brasil SA.; Biomerieux S.A