Device Recall Perkin Elmer NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Perkinelmer 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
    63771
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0686-2013
  • 사례 시작날짜
    2012-11-26
  • 사례 출판 날짜
    2013-01-16
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2014-03-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Ninhydrin and l-leucyl-l-alanine (fluorimetric), phenylalanine - Product Code JNB
  • 원인
    Truncated v-bottomed microplate wells used in assays contain defective wells.
  • 조치
    Perkin Elmer initiated the recall on November 23, 2012. The Recall Letter will be delivered to the end customer by email facilitated through our PerkinElmer Technical Support group located in Akron Ohio. Technical Support will be asked to make sure the customers receive the Recall Letter and implement the recommended precautions: - Inspect the wells of row A and row H of the affected microplate lots for possible holes and cracks prior to use. - If a hole or crack is visually detected in a well of the microplate, the well should not be used for testing. - If a hole or crack is not visually detected in a well of the plate, it is required during use of the well, the volume of solution in the well should be visually confirmed to be consistent before and after incubation. Please contact PerkinEimer Technical Support for further information (800) 321 -9632, select prompt 2.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 617341, 619236
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM || MASS SPECTROMETRY KIT || Product Number: 3026-0030. || This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper. (Table 1 of Attachment 2) details the analytes measured by the kit. Quantitative analysis of amino acids, free carnitine and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that may aid in the screening of newborns for one or more of several metabolic disorders. This kit is to be used for in vitro diagnostic use only, by trained, qualified laboratory personnel.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Perkinelmer, 940 Winter Street, Waltham MA 02451
  • 제조사 모회사 (2017)
  • Source
    USFDA