Events

VITROS for Glucose GLUT / Lactate LAC / TRIGLYCERIDES TRIG / URIDO URIC Technical Name: Glucose / Lactate / TRIGLYCERIDES / URIC ACID Registration Number ANVISA: 10132590235 Hazard Class: II Affected Model: Dry Reactive VITROS for Glucose GLU / Lactate LAC / TRIGLYCERIDES TRIG / URIC ACID URIC Serial Numbers Affected: SKU: 1707801 | Lots: GENs 10, 11, 20 to 31; SKU: 8433880 and 8150112 | Lots: GENs 30, 31; SKU: 1336544 and 8329930 | Lots: GENs 16, 17, 19, 20, 22, 23, 24, 25, 27 to 32; SKU: 1943927 | Lots: GENs 26, 27, 28, 29, 31 Due to the volume of impacted products, the company chooses to notify all customers that possess the equipment that can be used for such dry reagents. Therefore, customers who have the VITROS 250/350, 4600, 5600 and / or 5.1 FS System equipment will be notified. 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 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
    2105
  • 날짜
    2016-09-12
  • 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
    • Before receiving the revised Instructions for Use (IFU), be aware that misaligned results may occur in patient samples containing these substances. Follow your normal laboratory procedures, as you would for other known test interferences. Note: It is acceptable to continue using the affected VITROS Dry Reaction Tests. • Talk to your Lab Medical Director about any questions regarding previously reported results to determine the appropriate course of action. • Place this notification on your VITROS System or along with your user documentation. • In compliance with regulatory requirements, complete the Receipt Confirmation Form.
  • 원인
    Ortho clinical diagnostics (ortho) became aware of new information on the potential for n-acetylcysteine ​​(nac) interference in some specific tests with the vitros dry reagents for glucose, lactate, triglycerides and uric acid. patients who received nac may potentially have sample results with deviations. because of this problem, we are initiating this urgent product fix. n-acetylcysteine ​​is a drug primarily used to treat paracetamol overdosage, but the drug is also used as a mucolytic therapy in the treatment of lung diseases and inhalation injury in children. nac is also used as a nutritional supplement.
  • 조치
    Field Action Code 16000112 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will update, correct or supplement the instructions for use.

Device

VITROS for Glucose GLUT / Lactate LAC / TRIGLYCERIDES TRIG / URIDO URIC Technical Name: Glucose /...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Ortho Clinical Diagnostics