Events

ARCHITECT Total T3 Reagent Kit 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Ireland Diagnostics Division 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
    69289
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0474-2015
  • 사례 시작날짜
    2014-09-11
  • 사례 출판 날짜
    2014-12-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130168
  • 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
    Radioimmunoassay, total triiodothyronine - Product Code CDP
  • 원인
    17% of architect total t3 reagent kit, ln 7k64-20/-25 reagent lots 38901ui00 and 38901ui01 may exhibit lower relative light units (rlus) than expected, which in turn may result in controls out of range or patient results higher than expected.
  • 조치
    Abbott sent an Product Recall letter dated September 11, 2014, to all direct accounts (customers). The letters included instructions for customers to: 1) Discontinue use of and destroy any remaining inventory according to your laboratory procedures; 2) follow your laboratory protocol regarding the need for review of previously reported patient results; 3) replacement material is available; for ordering, please order through your normal ordering process; and, 4) if you have forwarded any of the affected lots to another laboratory, please provide them with a copy of this communication. Customers or healthcare providers with questions can contact Customer Service at 1-877-422-2688 (24 hours a day, 7 days a week).

Device

ARCHITECT Total T3 Reagent Kit
  • 모델명 / 제조번호(시리얼번호)
    Product List Numbers, Lot Numbers, and Expiration Dates:   1) List Number: 7K64-20, Lot Number 38901UI00, Expires: 29-Jan-15;  2) List Number: 7K64-25; Lot Number 38901UI01, Expires: 29-Jan-15
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including Puerto Rico and the states of AL , AR , AZ , CA , CT , FL , GA , IL , IN , KS , LA , MA , MD , MI , MN , MO , MS , MT , NC , NJ , NV , NY , OH , OK , PA , SC , SD , TN , TX , UT , VA , WA , WI and WV., and the countries of : Andorra , Angola , Argentina , Armenia , Austria , Azerbaijan , Bangladesh , Barbados , Belarus , Belgium , Bosnia & Herzegovina , Brazil , Burkina Faso , Canada , Cayman Islands , Chile , China , Colombia , Costa Rica , Croatia , Czech Republic , Ecuador , Egypt , El Salvador , Ethopia , Georgia , Germany , Greece , Greenland , Guatemala , Honduras , Hong Kong , India , Indonesia , Iran , Ireland , Israel , Italy , Jamaica , Japan , Kazakhstan , Kenya , Korea , Kuwait , Latvia , Lebanon , Libya , Malaysia , Mexico , Moldova , Montenegro , Oman , Pakistan , Gaza & Jericho , Panama , Paraguay , Peru , Philippines , Poland , Portugal , Qatar , Romania , Russia , Saudi Arabia , Serbia , Singapore , Slovakia , Spain , Sri Lanka. , Switzerland , Taiwan , Tajikistan , Thailand , The Netherlands , Trinidad & Tobago , Turkey , Ukraine ,United Arab Emirates , United Kingdom , Venezuela , Vietnam and Yemen.
  • 제품 설명
    ARCHITECT Total T3 Reagent Kit (7K64) consists of: || - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. || - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. || The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma.
  • Manufacturer
    Abbott Ireland Diagnostics Division

Manufacturer

Abbott Ireland Diagnostics Division
  • 제조사 주소
    Abbott Ireland Diagnostics Division, Lisnamuck, Co. Longford Ireland
  • 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
    USFDA