Events

Device Recall QUANTALyser 240 IFA 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Inova Diagnostics Incorporated 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    79380
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1221-2018
  • 사례 시작날짜
    2018-01-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162171
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • 원인
    The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.
  • 조치
    The letters were issued via email on January 26, 2018, informing the consignee of the issue and the actions to be taken. The response forms were requested to be completed and returned by February 23, 2018, indicating receipt of the notification and confirmation that the power supply has been replaced. The firm reported on February 23, 2018 that responses have been received from both consignees. For further questions, please call (858) 586-9900 x 1381.

Device

Device Recall QUANTALyser 240 IFA
  • 모델명 / 제조번호(시리얼번호)
    Serial number 4314
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    There was no U.S. distribution. Distribution was made to Panama and United Kingdom.
  • 제품 설명
    QUANTA-Lyser 240 IFA, Part #GS0242. || The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in the preparation for microscope analysis, and photometric measurement of microwell plates.
  • Manufacturer
    Inova Diagnostics Incorporated

Manufacturer

Inova Diagnostics Incorporated
  • 제조사 주소
    Inova Diagnostics Incorporated, 9900 Old Grove Rd, San Diego CA 92131-1638
  • 제조사 모회사 (2017)
    Werfenlife Sa.
  • Source
    USFDA