Events

Device Recall SP hCG Cassette Rapid Test 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
    49026
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-1344-2013
  • 사례 시작날짜
    2013-01-21
  • 사례 출판 날짜
    2013-05-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-08-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72543
  • 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
    Alere san diego inc. is recalling the cardinal health hcg cassette rapid test because some of them were incorrectly packaged into cardinal health hcg combo rapid test kit boxes. the kit box incorrectly indicates the product may be used for both urine and serum sample types.
  • 조치
    The firm, Alere, sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 21, 2013 to all their customers. The letter describes the product, problems identified and the actions to be taken. Customers are instructed to discontinue use and/or sale of the product; immediately discard all units of the the product in accordance with your local regulations; share this information with your laboratory staff and retain this letter for your records; if you have forwarded the product to another laboratory, provide a copy of this letter to them and include the name, address and a contact for the laboratory on the enclosed Customer Verification Form; complete and return the Customer Verification Form within 10 days via fax to: Technical Service at 858-805-8457 or e-mail to responses.ts@alere.com. Customers with any questions are instructed to contact Alere Technical Services at (866) 216-0094 or by email at lateral.flow.support@alere.com.

Device

Device Recall SP hCG Cassette Rapid Test
  • 모델명 / 제조번호(시리얼번호)
    Lot: hCG2080330
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including states of: AL, AK, AR, AZ, CA, CO, CT, DE, HI, IA, ID, IL, IN, FL, GA, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, UT, TN, TX, VA, WA, WI, WV AND WY.
  • 제품 설명
    Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) || The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use.
  • 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