Events

Products Affected: VITROS ANALYZING SYSTEM / CHEMICAL SYSTEM VITROS 4600 / CHEMICAL SYSTEM VITROS 5600 / CHEMICAL SYSTEM VITROS 5.1 FUSION. Anvisa Registers: 10132590681. VITROS® 250 System (Reg ANVISA 10132590681). VITROS® 350 System (Reg ANVISA 10132590681). VITROS® 4600 Chemical System (Reg ANVISA 80145901335). VITROS® 5600 Integrated System (Reg ANVISA 80145901205). VITROS® 5.1 Fusion Chemical System (Reg ANVISA 80145900827). Risk class: II. Affected Series / Lots: Includes all VITROS® 250, 350, 4600, 5600 and 5.1FS Diagnostic Systems. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.; ORTHO CLINICAL DIAGNOSTICS, INC 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
    1805
  • 날짜
    2016-01-25
  • 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
  • 원인
    Condition codes u90-382 or 6lu are associated with lavage errors that may occur when using vitros® chemicals for immunoenzymatic assays (vitros® crbm, crp, dgxn and phyt slides). if a u90-382 or 6lu condition code associated with a wash error occurs, the condition code text located on the vitros® system and other user documents indicates to dilute the sample. however, dilution may not be the appropriate action in all cases.
  • 조치
    a) Field action classification: Field correction with software update b) Field action code: 15000183 c) Recommendations to users and patients: For results indicated with a Wash Error code - WE: Follow the recommended actions described in your user documentation. • If a single sample has been diluted and reprocessed: o If the calculated result in the diluted sample exceeds the measuring range, the result will be acceptable. o If the WE code in the same sample occurs again or the calculated result does not exceed the measurement range, use an alternative method to perform the test. • Place this notification on your VITROS® System or along with your user documentation.

Device

Products Affected: VITROS ANALYZING SYSTEM / CHEMICAL SYSTEM VITROS 4600 / CHEMICAL SYSTEM VITROS...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda.; ORTHO CLINICAL DIAGNOSTICS, INC