Events

Product Name: LYRA II AGLUTINATION REACTION READER - Log: 80004040165 - Model: 854002 - Affected batches / series: 407; 422; 423; 424; 434; 451; 453; 454; 461; 462; 465; 468; 471; LY0H000201; LY0H000203; LY0K000303; LY0K000305; LY0K000306; LY1B000401; LY1B000402; LY1B000403; LY1B000409; LY2C003904; LY2C004004; LY3F007301; LY3F007302; LY3F007303; LY3F007304; LY3F007308; LY3I007507; LYB000407; LYB000410 (SEE SCHEDULE OF DISTRIBUTION IN ANNEX) 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 DIAMED LATINO AMÉRICA 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
    1643
  • 날짜
    2015-07-27
  • 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
    Immediate Protective Action - Customer Guidelines: • Use only an empty microplate for balancing purposes. For example: when only one microplate is read; • Check the color of the results presented by the Maestro software during validation; • Do not validate results if well images appear in black and white.
  • 원인
    It has been shown that in exceptional circumstances, the lyra ii agglutination reaction reader software (ms registry 80004040165) may incorrectly attribute the result of a microplate previously read to the microplate being processed. when this occurs, incorrect results are displayed in black and white instead of colored. according to a company risk assessment, "the likelihood of reporting an erroneous outcome is very limited, since the occurrence of this event is associated with several random factors occurring simultaneously. to date, no incident with patient has been reported.".
  • 조치
    Company is informing its customers about the problem so that they take the appropriate preventive measures until a definitive solution is released through a new software version. It is reported that "the probability of reporting an erroneous result is very limited, since the occurrence of this event is associated with several random factors occurring simultaneously." To date, no incident with patient has been reported. "; Action: Update, correction or supplementation of the instructions for use Code: AC 2015/02 SEE ATTACHMENTS: (i). Important Notice of Field (AC) - AC Number: 2015/02; (ii) .CORRECTIVE ACTION NOTIFICATION ACKNOWLEDGMENT (AC 2015/02)

Device

Product Name: LYRA II AGLUTINATION REACTION READER - Log: 80004040165 - Model: 854002 - Affected ...

Manufacturer

DIAMED LATINO AMÉRICA S.A.