Events

Device Recall HemosIL PTFibrinogen HS PLUS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Instrumentation Laboratory Co. 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
    69824
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0832-2015
  • 사례 시작날짜
    2014-11-21
  • 사례 출판 날짜
    2014-12-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-01-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131733
  • 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
    Test, time, prothrombin - Product Code GJS
  • 원인
    Some vials of hemosil pt-fibrinogen hs plus, part no. 0008469810 (various lots manufactured prior to june 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of the typical white to off-white color. vials exhibiting this yellow/brownish color were observed to cause prolonged prothrombin (pt) clotting times.
  • 조치
    The firm, Instrumentation Laboratory, sent an "URGENT MEDICAL DEVICE CORRECTION" letter (dated 11/21/2014) to US and Canadian customers via USPS on 11/21/2014 for all in-date lots of HemosiL PT-Fibrinogen HS PLUS, Part No. 0008469810, manufactured prior to June 2014. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: if they observe any yellow/brownish color after reconstitution, they are not to use the affected vial; discard the vial and reconstitute another vial; only use a vial if the reconstituted color is the typical white to off-white color; run quality controls at least once every 8 hour shift in accordance with GLP and insert instruction sheet; share this information with your laboratory staff and follow initial procedures; forward this notification to all affected locations within your facility; retain a copy of this notification for your records and complete and return the tracking record form within 10 business days of receiving notification even if you do not use these reagents via fax at 781-861-4207 or email to: ra-usa@ilww.com. On 11/21/2014, e-mail notifications were sent to the IL/Werfen Country Affiliates and International Group (who manage the local country dealers and distributors) to prepare and issue Field Safety Notices in the respective languages to their customers. For technical questions, please contact the IL Technical Support Center at 1-800-678-0710, Option # 2 (ACL Coagulation Products). For additional questions, please contact your IL Customer Service Representative at 1-800-955-9525, Option # 2.

Device

Device Recall HemosIL PTFibrinogen HS PLUS
  • 모델명 / 제조번호(시리얼번호)
    Lots: N1122175, exp. date 11/30/2014;  N0132936, exp. date 1/31/2015; N0233302, exp. date 2/28/2015; N0333382, exp. date 3/31/2015; E0333382, exp. date 3/31/2015; N0333626, exp. date 3/31/2015; N0433932, exp. date 4/30/2015; N0634953, exp. date 6/30/2015; N0735317, exp. date 5/31/2015; N0735599, exp. date 7/31/ 2015; N0836106, exp. date 8/31/2015; N0936197, exp. date 9/30/2015;  N0349325, exp. date 12/31/2015; N1222324, exp. date 12/31/2015; N0148094, exp. date 12/31/2015;  N0248652, exp. date 2/29/2016; N0249017, exp. date 2/29/2016;  N0449790, exp. date 4/30/2016; N0440009, exp. date 4/30/2016.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) including Puerto Rico; and countries of: ALBANIA, ALGERIA, ANDORRA, ARGENTINA, ARMENIA, AUSTRALIA, AUSTRIA, BELARUS, BRAZIL, BRUNEI, BULGARIA, CHILE, CHINA, COLUMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, FRANCE, GABON, GEORGIA, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, KENYA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA, MEXICO, NEW ZEALAND, PAKISTAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, SRI LANKA, SWITZERLAND, TURKEY, UAE, UGANDA, UKRAINE, UNITED KINGDOM, AND URUGUAY.
  • 제품 설명
    HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. || A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
  • Manufacturer
    Instrumentation Laboratory Co.

Manufacturer

Instrumentation Laboratory Co.
  • 제조사 주소
    Instrumentation Laboratory Co., 180 Hartwell Road, Bedford MA 01730-2443
  • 제조사 모회사 (2017)
    Werfenlife Sa.
  • Source
    USFDA