Events

Device Recall MagNA Pure LightCycler 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Roche Diagnostics Operations, 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
    59370
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3078-2011
  • 사례 시작날짜
    2011-07-21
  • 사례 출판 날짜
    2011-08-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102425
  • 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
    Automated System; Nucleic Acids Isolation - Product Code LXG
  • 원인
    Roche has detected a problem with the magna pure lc 1.0 (software version 3.0.11) and the magna pure lc 2.0 (software versions 1.1.23 and 1.1.24) instruments. under certain circumstances, only a fraction of each sample is processed which may lead to false negative results, and an impact to patient health if used in a homebrew diagnostic application.
  • 조치
    Roche Diagnostics Operations, Inc. sent a letter dated July 21, 2011 entitled "URGENT MEDICAL DEVICE CORRECTION" to all affected customers. The letter included the name product, software versions, and reason for recall and informed them the problem is under investigation. In the meantime, customers are asked to wait 30 seconds after the finalization of the decontamination cycle before initiating the next operation, in order to avoid this issue. For questions on this recall please call Roche at (800) 428-5074.

Device

Device Recall MagNA Pure LightCycler
  • 모델명 / 제조번호(시리얼번호)
    Series 2.0 software version 1.1.23 and 1.1.24, Part number 05197686001, Ser Numbers LC2C00000383, LC2C00000566, LC2C00000572, LC2C00000428, LC2C00000482, LC2C00000266, LC2C00000192, LC2C00000216, LC2C00000233, LC2C00000419, LC2C00000531, LC2C00000033, LC2C00000583, LC2C00000127, LC2C00000170, LC2C00000563, LC2C00000234, LC2C00000561, LC2C00000205, LC2C00000394, LC2C00000329, LC2C00000418, LC2C00000420, LC2C00000569, LC2C00000570, LC2C00000564, LC2C00000486, LC2C00000483, LC2C00000158, LC2C00000214, LC2C00000215, LC2C00000265, LC2C00000309, LC2C00000217, LC2C00000254, LC2C00000081, LC2C00000159, LC2C00000212, LC2C00000213, LC2C00000293, LC2C00000427, LC2C00000232, LC2C00000242, LC2C00000134, LC2C00000168, LC2C00000219, LC2C00000479, LC2C00000228, LC2C00000580, LC2C00000243, LC2C00000263, LC2C00000393, LC2C00000155, LC2C00000203, LC2C00000204, LC2C00000267, LC2C00000268, LC2C00000193, LC2C00000206, LC2C00000381, LC2C00000381, LC2C00000429, LC2C00000588, LC2C00000449, LC2C00000218, LC2C00000253, LC2C00000110, LC2C00000156, LC2C00000128, LC2C00000162, LC2C00000178, LC2C00000118, LC2C00000079, LC2C00000273, LC2C00000431, LC2C00000477, LC2C00000196, LC2C00000130, LC2C00000310, LC2C00000264, LC2C00000414, LC2C00000276, LC2C00000312, LC2C00000313, LC2C00000361, LC2C00000363, LC2C00000331, LC2C00000330, LC2C00000236, LC2C00000360, LC2C00000294, LC2C00000298, LC2C00000532, LC2C00000220, LC2C00000270, LC2C00000413, LC2C00000120, LC2C00000274, LC2C00000227, LC2C00000384, LC2C00000275, LC2C00000364, LC2C00000269, LC2C00000252, LC2C00000119, LC2C00000250, LC2C00000235, LC2C00000169, LC2C00000244, LC2C00000108, LC2C00000256, LC2C00000272, LC2C00000173, LC2C00000582, LC2C00000064, LC2C00000255, LC2C00000179, LC2C00000562, LC2C00000581, LC2C00000035, LC2C00000080, LC2C00000172, LC2C00000412, LC2C00000032, LC2C00000131, LC2C00000195, LC2B00000042, LC2C00000039, LC2C00000043, LC2C00000034, LC2C00000132, LC2C00000133, LC2C00000060, LC2C00000180, LC2C00000578, LC2C00000314, LC2C00000571, 2C00000565, LC2C00000415, LC2C00000430, LC00000529, LC2C00000044, LC2C00000129, LC2C00000297, LC2C00000358, LC2C00000359, LC2C00000392 and LC2C00000434.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution; including the islands of Puerto Rico and Hawaii.
  • 제품 설명
    MagNA Pure LC 2.0 (software version 1.1.23 and 1.1.24) || Roche Diagnostics Operations, Inc. || An automated instrument used for isolation of nucleic acids (DNA, total RNA, total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96-well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for the making of dilution series, reaction mixes.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • 제조사 주소
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256-1025
  • 제조사 모회사 (2017)
    Roche Holding AG
  • Source
    USFDA