Events

S2 FLUID PACK OMNI S, Registration: 10287410150, Lots: 21450781/21450887/21451391 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH 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
    1630
  • 날짜
    2015-07-08
  • 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
    The company informs that when an affected S2 Fluid Pack is inserted into the cobas b 221 instrument, it will display the error message "Transponder error" and the instrument can not start the measurement until the affected S2 Fluid Pack is replaced by a packaging that does not present a defect and may lead to a delay in the measurement of the parameters. If the equipment correctly identifies the package, the measurement will proceed normally as there are no problems with the reagent.
  • 원인
    Roche diagnostics gmbh, the manufacturer of the products involved in this notification, after internal investigations identified a possible increase in the generation of transponder errors specific to s2 fluid pack reagent packs from lots 21450781, 21450887 and 21451391. such an error is detected and generated by equipment as soon as an affected s2 fluid pack is inserted, making it impossible to use it. the company informs that not all packs of fluid pack from these batches have been affected and the only way to identify whether or not the product is affected is by inserting the fluid pack fluid pack into the instrument and checking if an error message is indicated.
  • 조치
    The company advises that: i) S2 Fluid Pack packages should be replaced if "Transponder error" is indicated. The affected Fluid Pack packaging must be disposed of locally. ii) In case the customer finds the message "Transponder error", we request that you contact our service center CEAC - 08007720295 for treatment of the occurrence.

Device

S2 FLUID PACK OMNI S, Registration: 10287410150, Lots: 21450781/21450887/21451391

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH