Events

Nuclisens easyMag Magnetic Silica Technical Name: Nuclisens easyMag Magnetic Silica ANVISA Registration Number: 10158120569 Hazard Class: I Affected Model: Serial Numbers Affected: Z017DA1MS (Expired on 04/28/2017) 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 bioMérieux S.A. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    2071
  • 날짜
    2016-07-08
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    1-Distribute information on the problem with Nuclisens easyMam MangeticSilica to all technical personnel in the laboratory, keep a copy in the technical files, share the information with everyone who can use the product, including others to whom you are interested. distributing the lot concerned. 2- Reduce the sample to be tested to a volume of at most 200uL, until the occurrence of the product is not identified until the Silica is changed. 3- Use an internal extraction control that mimics the objective (same nature / structure) or external controls as directed at the product line and the GLP, to detect any performance problems in the extraction. 4- Discuss any technical questions you may have, prior to issuing the results of your lab, to your lab's Medical Director to determine the appropriate course of action. 5- Contact the bioMérieux Brasil customer service team if you notice the problem. 6 - Cmplete and return the Knowledge form, so that we can register the receipt of the letter and the guidelines by your institution. #### 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.
  • 원인
    Some customer complaints were recorded when in-house methodologies were applied for pcr and rt-pcr assays. customers complained about performance problems in amplification when they used different batches of magnetic silica (ref. 280133) as well as the nuclisens easymag extraction platform. this is due to the variability in the quality of magnetic silica. the difference above 1 log in quantification was observed for some clients when using their own in-house validation methodology for dna assays. the difference of 1log is significant about the results. as the donwstream applications are qualitative and / or quantitative methods, the decrease in the performance of this application can lead to: 1- risk of false negative for qualitative tests; 2- invalid resets, when the control of the internal application is not within the specifications; 3 subquantified results for quantitative tests. all customers who complained identified the problem with the help of internal and external extraction controls either directly on the kit's objective or during check-in control when switching from one batch of silica to another. the investigation (pr 978900) identified impact in: 1- extraction volumes greater than 400ul; 2- double-stranded nucleic acid targeting assays; 3- the size of the genome to be detected 4 aggravating factor: applications for small double-stranded nucleic acids (<40kbp) and medium genomes (<1200 kbp), eg. dna viruses, are more impacted than superior human genomes or bacterial applications (> 1200kbp).
  • 조치
    Field Action Code FSCA 3037 triggered under the responsibility of bioMérieux. Company will make correction in the field.

Device

Nuclisens easyMag Magnetic Silica Technical Name: Nuclisens easyMag Magnetic Silica ANVISA Regist...

Manufacturer

bioMérieux S.A.