Events

ZYM B, registration number 10158120560, hazard class I, lots: 1003765610, 1003772410, 1003772470, 1003787970, 1003790030, 1004077210, 1004097610, 1004355410, 1004355730. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Biomerieux Brasil SA.; 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
    1798
  • 날짜
    2015-01-15
  • 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
    According to the company, a corrective action plan was initiated to define the root cause and determine the long-term action plan to resolve the non-compliance. As a result of the ZYM B performance change, the reported risk is potentially a negative result of some API tests, misidentification of some species with API 20 Strep, NH API, Listeria API and Coryne API. Staph API is not affected by a risk of misidentification. As for ZYM API, since it was designed to search for enzymatic activities, there is no risk of error of identification of microorganisms. The simulation was done with the API databases of each gallery API involved, in order to understand the impact of a negative result of these tests on the final identification result. ### 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.
  • 원인
    Discrepancies in identification related to identification galleries api. these discrepant identification results are due to false negative results in gallon tests revealed by the use of zym b reagent. the investigation confirmed a loss of performance due to light exposure after 3 months of life for zym b api, which could lead to to false negative results from biochemical tests using zym b reagent in all api galleries quoted below: strep api 20, coryne api, staph api, zym api, nh api, listeria api.
  • 조치
    Letter of Letter to the Client. Action Code: FSCA 2752. Forwarded LETTER to customers, requesting that they distribute the information to all appropriate personnel in the laboratory, keeping a copy in their files, and transmitting this information to all parties who may use this product. The company informs customers that they will continue to use the ZYM B kits that are still in stock with a mandatory requirement before using a ZYM B ampoule, and each day of using the API galleries: conduct quality control with the ATCC strains , as described in each package of API galleries involved and as described in the Letter to Customers (see annex). In addition, it is necessary to protect the ZYM B light exposure kit as described in the package insert. ////// The company is working on a long-term solution to improve the robustness of the ZYM B reagent. A note will be added on the future packaging of ZYM B to explain the required actions required in the letter to the customer.

Device

ZYM B, registration number 10158120560, hazard class I, lots: 1003765610, 1003772410, 1003772470,...

Manufacturer

Biomerieux Brasil SA.; Biomérieux S.A.