Events

Device Recall ARCHITECT Intact PTH Calibrators 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Abbott Laboratories 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
    67527
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1671-2014
  • 사례 시작날짜
    2014-02-12
  • 사례 출판 날짜
    2014-05-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-05-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125677
  • 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
    Calibrator, secondary - Product Code JIT
  • 원인
    Abbott has confirmed that a performance shift in the architect intact pth assay has the potential to generate falsely elevated results on patient samples. results generated with impacted lots may demonstrate a positive shift relative to those generated with previous calibrator and/or control lots. the issue may also impact your established architect intact pth reference ranges. abbott architect in.
  • 조치
    Product Information letters dated August 23, 2013 were sent to all direct accounts alerting the direct accounts to a positive bias observed in test results using some of the affected kits. The letter advised the direct accounts to take this information into account when interpreting patient results. Customers with questions were advised to contact Customer Service at 877-4ABBOTT (877-422-2688) (24 hours a day, 7 days a week) and to refer to Product Information Letter PI23AUG2013. Product Recall letters dated February 12, 2014 were sent to all direct accounts. The letter included instructions to: 1) immediately discontinue the use of, and destroy, any remaining inventory of ARCHITECT Intact PTH assay according to each customer's laboratory practices; 2) to continue Intact PTH testing at your laboratory, Abbott recommends that customers identify an alternate method for testing patient samples; 3) if further guidance is needed, please contact the customers's Abbott sales representative; 4) review the letter with the treating physician or healthcare provider to ensure they are aware of the issue and can determine whether re-evaluation of the patient is necessary, and that Abbott included a physician letter that you can use to notify your ordering physicians of this issue; 5) If the customer forwarded any product to other laboratories, please inform them of this Product Recall and provide a copy of the recall letter, customer reply, and physician letter to them; and, 6) complete and return the Customer Reply. Customers with questions were advised to contact Customer Service at 877-4ABBOTT (877-422-2688) (24 hours a day, 7 days a week).

Device

Device Recall ARCHITECT Intact PTH Calibrators
  • 모델명 / 제조번호(시리얼번호)
    List Number: 8K25-01. Lot Numbers and Expiration Dates: Lot 00613I000, Expires 05 SEP 2014; Lot 01913C000, Expires 14 MAR 2014; Lot 01913K000, Expires 12 NOV 2014; Lot 02413E000, Expires 09 MAY 2014; Lot 01312K000, Expires 12 NOV 2013; Lot 00813A000, Expires 08 JAN 2014; Lot 01412H000, Expires 16 AUG 2013; Lot 00912F000, Expires 30 MAY 2013.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide including District of Columbia and Puerto Rico; Algeria, Andorra, Angola, Argentina, Armenia, Austria, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belgium, Bosnia & Herzegovina, Brazil, Brunei, Bulgaria, Cameroon, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gaza and Jericho, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, ITALY, Jamaica, Japan, Jordan, Kenya, Korea (South Korea), Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Palestine, Panama, Panam¿, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, San Marino, Saudi, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, SPAIN, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Ukraine, Uruguay, Venezuela, Vietnam, and Yemen
  • 제품 설명
    ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300. || Product Usage: || The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System.
  • Manufacturer
    Abbott Laboratories

Manufacturer

Abbott Laboratories
  • 제조사 주소
    Abbott Laboratories, 100 Abbott Park Rd, Abbott Park IL 60064-3502
  • 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