Events

Mucolexx / Mucolytic Agent 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Richard-Allan Scientific Company 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
    71178
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1639-2015
  • 사례 시작날짜
    2015-04-29
  • 사례 출판 날짜
    2015-05-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-03-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136396
  • 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
    Preservative, cytological - Product Code LEA
  • 원인
    Richard allan scientific (ras) is initiating a recall of mucolytic agent and mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots of mucolexx.
  • 조치
    Richard Allan Scientific (RAS) initiated a voluntary recall of Mucolexx and Mucolytic Agent due to fungal contamination on 5/1/2015 via certified mail to all customers who received the affected. Customers were asked to return a repsonse form, and dispose or return all recalled products. Please contact Sarah Rickert at 269-544-5628 or sarah.rickert@thermofisher

Device

Mucolexx / Mucolytic Agent
  • 모델명 / 제조번호(시리얼번호)
    Richard Allan Scientific Mucolytic Agent 1 pint / 473 ml Product code: 76166, Lot #s and EXP Dates: 313839-Dec 2016; 311157-Oct-2016; 306726-Aug-2016; 297142-Jun-2016; 296289-May-2016; 290486-Mar-2016; 289488-Mar-2016; 276824-Nov-2015; 271110-Oct-2015; 265368-Aug-2015.  Richard Allan Scientific Mucolytic Agent 1 gallon/ 3.8 l, Product Code: 76167; Lot Number & EXP Dates: 311158- Oct-2016; 302099- Jun-2016; 298834-Jun-2016; 293734- Apr-2016; 288009-Feb-2016; 283396-Jan-2016; 279581-Nov-2015; and 274814- Oct-2015  Dec-2016 Oct-2016 Aug-2016 Jun-2016 May-2016 Mar-2016 Mar-2016 Nov-2015 Oct-2015 Aug-2015
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of: AR; AZ; CA; CO; FL; GA; I A; IL; IN; KY; MA; MN; MO; MS; MT; NC; ND; NJ; NV; NY; OH; OK; PA; PR; SD; TN; TX; VA; WA; WI and the countries of: Bangladesh, Canada, China, Costa Rica, Dubai, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Korea, Netherlands, Panama, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and UK.
  • 제품 설명
    Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l || Product Usage: || A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results.
  • Manufacturer
    Richard-Allan Scientific Company

Manufacturer

Richard-Allan Scientific Company
  • 제조사 주소
    Richard-Allan Scientific Company, 4481 Campus Dr, Kalamazoo MI 49008-2590
  • 제조사 모회사 (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA