Events

Safety Alert for MicroScan Pos Combo Panel Type 41, culture medium, Beckman Coulter brand, registration 10033120934, hazard class II, lot: 2016-05-04.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Beckman Coulter do Brasil Comércio e Importação de Produtos for Laboratórios Ltda.; Beckman Coulter Inc..

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
    1793
  • Date
    2015-01-08
  • 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 VP test is used for the identification of gram positive cocci gram-negative catalase, PYR negative and bile esculin negative. This specific test is used for differentiation of the Streptococcus species from the viridans Group, being of epidemiological importance, since the whole group has the same pathogenicity. /// If the panel is used for isolated clinical testing, the impact is potential for any of the following combinations: high probability of misidentification, poor likelihood of identification or very rare biotypes due to incorrect VP results.
  • Reason
    The results would be falsely negative for the voges-proskauer (pv) test (light pink / brown / colorless) with the quality control (qc) of the organism staphlococcus aureus atcc 29213. the expected result is positive for this test.
  • Action
    Collection and destruction of culture media. Action code: FA-26321. The company directs to stop the use of the medium and discard any remaining stock from the lot quoted. Fill out and send to the record holder a form requesting the replacement of the product. Keep inventory of other batch numbers in this panel because you are not affected by this problem. Discuss the content of the action with the laboratory director regarding the need to analyze the results of previous tests, propose follow-up of the patient or repeat the test using another panel batch if the isolates are still available.

Device

MicroScan Pos Combo Panel Type 41, culture medium, Beckman Coulter brand, registration 1003312093...

Manufacturer

Beckman Coulter do Brasil Comércio e Importação de Produtos for Laboratórios Ltda.; Beckman Coult...