Events

Safety Alert for Xpert BCR-ABL Monitor Technical Name: Chromosome Translocation BCR-ABL Registration Number ANVISA: 81062710016 Hazard Class: III Affected Model: Kit with 10 tests (cartridges with integrated reaction tubes) Serial numbers affected: LOT: 1000041807

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by CEPHEID BRASIL IMPORTAÇÃO, EXPORTAÇÃO E COMÉRCIO DE PRODUTOS DE DIGANÓSTICOS LTDA.; CEPHEID.

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
    2311
  • Date
    2017-06-13
  • 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 proposed action to address device failures is to send customers a Field Security Notification (FSN), which informs customers to stop using the BCR-ABL Monitor product, lot 1000041807, which will later be collected by the company.
  • Reason
    A new test method for bcr-abl monitor shows that performance deteriorates after 12 months when stored at 2-28 ° c. the d10939 rev k stability report reduces the stability validity from 24 months to 12 months for the xpert bcr-abl monitor products. analysis of the mode of failure of bcr-abl in relation to the impact of the product result on the patient: stability data from the assay beyond 13 months sub-reported the amount of bcr-abl mrna transcript at the lowest level tested, 1%. the reported performance of the xpert bcr-abl monitor assay allows a 2-fold variance in the ratio of bcr-abl mrna transcripts to abl, considering that at 25 months, we observed a 3-fold difference. at 13 months, a variance of 1.8 times was observed, which is within the variability of performance of the declared product. although beyond the stability limits, the detected level of transcription of bcr-abl mrna is correctly termed as the bcr-abl detected.
  • Action
    Field Action Code CPHD-002/2017 triggered under the responsibility of the company Olympus Optical do Brasil Ltda. Company will collect for further destruction of the product.

Device

Xpert BCR-ABL Monitor Technical Name: Chromosome Translocation BCR-ABL Registration Number ANVISA...

Manufacturer

CEPHEID BRASIL IMPORTAÇÃO, EXPORTAÇÃO E COMÉRCIO DE PRODUTOS DE DIGANÓSTICOS LTDA.; CEPHEID