Events

Alere hCG Combo Cassette (20/10 mIU/mL) KIt 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alere San Diego, Inc. 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
    65048
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1401-2013
  • 사례 시작날짜
    2013-04-16
  • 사례 출판 날짜
    2013-05-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-10-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117797
  • 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
    Visual, pregnancy hCG, prescription use - Product Code JHI
  • 원인
    The firm initiated recall of alere" hcg combo cassette (20/10 miu/ml) kit pn 92215, lots hcg1110133 and hcg1110135, because an investigation has indicated a portion of these alere" hcg combo cassette (20/10 miu/ml) pn 92215 kit lots were incorrectly packaged with the alere" hcg cassette (20 miu/ml) pn 92210 product insert. the alere" hcg cassette (20 miu/ml) product insert contains information for.
  • 조치
    Alere initiated this recall by sending recall notification letters, titled "URGENT MEDICAL DEVICE RECALL", dated April 16, 2013 via via fax, email or direct mail. The letter informed customers of the product recalled, reason for recall, customer required action, and contact information, "Alere Technical Services at 866-216-0094 or by e-mail at lateral.flow.support@alere.com.". A verification form was attached to the notification letter.

Device

Alere hCG Combo Cassette (20/10 mIU/mL) KIt
  • 모델명 / 제조번호(시리얼번호)
    Lot/Unit Codes: hCG1110133 & hCG1110135  Part Number: 92215  Expiration date, or Expected shelf life: 9/30/13 & 10/31/13
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    United States Nationwide Distribution
  • 제품 설명
    Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. || Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only.
  • Manufacturer
    Alere San Diego, Inc.

Manufacturer

Alere San Diego, Inc.
  • 제조사 주소
    Alere San Diego, Inc., 9975 Summers Ridge Rd, San Diego CA 92121-2997
  • 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