Events

Device Recall lmmunalysis EDDP Urine Control Set 1 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Alere San Diego Inc. DBA Immunalysis Corporation 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
    80096
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-2140-2018
  • 사례 시작날짜
    2017-11-28
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164551
  • 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
    Enzyme immunoassay, methadone - Product Code DJR
  • 원인
    The high (125 ng/ml) control does not meet specification - it has been confirmed to produce values below 100 ng/ml when run on validated clinical chemistry analyzers, which is below the 100 ng/ml cutoff of the eddp specific urine enzyme immunoassay with which this control is utilized.
  • 조치
    On November 28, 2017, the firm sent their customer notifications of the recall stating the following: CUSTOMER REQUIRED ACTION 1. If you have product in your possession: " Immediately discontinue use and/or sale of affected product lot and place in quarantine. " Complete the enclose Customer Verification Form, within 10 days, indicating the quantity of product you have discarded or will return to lmmunalysis. " FAX completed Customer Verification Form to 909-482-0850 or scan and email to rtimbang@immunalysis.com " Upon receipt of your Customer Verification Form, we will initiate shipment of replacement product in the quantity indicated on the form and, if applicable, will contact you to arrange product return. " Return product as directed. 2. If you have no remaining product in your possession: " Complete the enclosed Customer Verification Form, within 10 days, indicating "We do not have any affected product - it has been consumed". " FAX completed Customer Verification Form to 909-482-0850 or scan and email to rtimbang@immunalysis.com 3. Share this information with your staff and retain this notification as part of your records. Please complete this form and return within 10 days even if you do not have any remaining product. Send form to lmmunalysis at Fax 909-482-0850 or by e-mail to rtimbang@immunalysis.com For further questions, please call (207) 730-5738.

Device

Device Recall lmmunalysis EDDP Urine Control Set 1
  • 모델명 / 제조번호(시리얼번호)
    Part Number: 3006-5, Lot Number: EK16135
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of : CA, CO, CT, FL, LA, MD, NC, NJ, OH, OK, TN, TX, WI, and WV
  • 제품 설명
    lmmunalysis EDDP Urine Control Set 1 || The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test result and a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Tandem Mass Spectrometry, must be used to obtain a confirmed analytical result.
  • Manufacturer
    Alere San Diego Inc. DBA Immunalysis Corporation

Manufacturer

Alere San Diego Inc. DBA Immunalysis Corporation
  • 제조사 주소
    Alere San Diego Inc. DBA Immunalysis Corporation, 829 Towne Center Dr, Pomona CA 91767-5901
  • 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