Events

ARCHITECT Free T4 Reagent 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Abbott Diagnostics Division 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2017-04-27
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • 데이터 추가 비고
  • 원인
    This product correction letter is being issued to provide you with information regarding a change of measuring interval for the architect free t4 assay list numbers 7k65‐29, 7k65‐34 and 7k65‐39. recent data generated by abbott have determined that the measuring interval is 0.40 ng/dl to 5.00 ng/dl. measuring interval is defined as the range of values in ng/dl which meets the limits of acceptable performance for both imprecision and linearity. the current measuring interval for list numbers 7k65‐29, 7k65‐34 and 7k65‐39 is 0.40 ng/dl to 6.00 ng/dl. a new ft4 assay file and updated package insert will be created reflecting the new measuring interval of 0.40 ng/dl to 5.00 ng/dl to be used with list numbers 7k65‐29, 7k65‐34 and 7k65‐39. .

Device

ARCHITECT Free T4 Reagent
  • 모델명 / 제조번호(시리얼번호)
    7K65‐29 100 Test Kit 65349UI00 N/A 65349UI01 N/A 68194UI00 N/A 68194UI01 N/A 68196UI00 N/A 68196UI01 N/A 71292UI00 N/A 71292UI01 N/A 71374UI00 N/A 71374UI01 N/A 7K65‐34 2000 Test Kit 65415UI00 N/A 68241UI01 N/A 70273UI01 N/A 71339UI00 N/A 73200UI01 N/A 74137UI00 N/A 7K65‐39 500 Test Kit 65415UI01 N/A 68241UI00 N/A 70273UI00 N/A 71339UI01 N/A 73200UI00 N/A 74137UI01 N/A
  • Manufacturer
    Abbott Diagnostics Division

Manufacturer

Abbott Diagnostics Division
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    AMPMDRS