Events

ARCHITEC Analyzer RS-232 Standard Interface Manual - Registration Number: 10055311134. ARCHITEC Software. V2.00 List Number 05F48-07. V2.01 List Number 05F48-08. V2.02 List Number 05F48-09. V2.03 List Number 05F48-10 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 ABBOTT LABORATÓRIOS DO BRASIL LTDA. DIVISÃO DIAGNÓSTICOS 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
    790
  • 날짜
    2004-08-17
  • 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 discrepancy exists between the number of characters allowed in the result that is sent to the ARCHITECT System (20 characters), and what is described in the ARCHITECT System's Standard RS-232 Interface Manual (15 characters). This manual states that the maximum number of characters allowed in the result field (ASTM Field 10.1.4) is 15 characters. The client uses the manual specifications to configure your server for bidirectional communications with the ARCHITECT System. When a client configures its server to accept only a result containing 15 characters or less, based on the RS-232 manual, and the ARCHITECT sends a result that is longer than 15 characters, it may not be accepted by the server or may be truncated. For example, if ARCHITECT sends "gray-zone reactive" text and the client server recognizes only 15 characters, this text may appear on the server as "gray-zone react", or the server may reject the entire transmission record, so that the data is not displayed. The server determines which of these results can occur, based on its schedule. If your ARCHITECT Analyzer is not connected to a Laboratory Information System (LIS) and / or if you are not using ARCHITECT Software Version 2.00 or higher, please disregard this information. ADDITIONAL INFORMATION Any questions or additional information, please contact the Abbott Customer Service Center Diagnostics Division - Phone 0800-11-9099.
  • 원인
    Discrepancy that exists between the maximum number of characters defined in the abbott rs-323 standard interface manual for the data value field and the number of characters that the architect software may attempt to send to this field.
  • 조치
    Corrective action for this occurrence is an update to the ARCHITECT Equipment RS-232 Standard Interface Manual to reset the maximum number of characters in the ASTM field from 15 to 20 characters. Immediate Action: Customer Letter (Important Product Information) has been distributed to all ARCHITECT customers who have ARCHITECT Software Versions 2.00 or higher. Future Distribution of Information: The current ARCHITECT i2000 module customers with Software version 1.6 were not affected by the occurrence. ARCHITECT i2000 clients upgrading to Version 2.1 software are not affected by this occurrence. Software modifications affecting the ARCHITECT System RS-232 Standard Interface Manual related to ASTM 10.1.4 Field are contained in version 2.00 or higher, and are applicable only to c8000 modules where user-defined testing is used. Abbott trials are not affected by this modification. New Customers - The ARCHITECT System RS-232 Standard Interface Manual, Listing No. 06F71-04 was placed in Quality Quarantine, 1016-2004. The product will be destroyed and a corrected version of the manual will be released, Listing No. 06F71-05

Device

ARCHITEC Analyzer RS-232 Standard Interface Manual - Registration Number: 10055311134. ARCHITEC S...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA. DIVISÃO DIAGNÓSTICOS
  • Source
    ANVSANVISA