Events

Device Recall Quantase Neonatal Elution Buffer 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bio-Rad Laboratories 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
    54551
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1562-2011
  • 사례 시작날짜
    2010-01-26
  • 사례 출판 날짜
    2011-03-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-03-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88703
  • 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
    Pressure contained within the elution buffer vial may expel the rubber stopper, causing the potential for injury.
  • 조치
    Direct accounts were notified by phone, followed by fax (domestic). Urgent Device Recall notification letters were sent out on January 26, 2010 to subsidiary along with a Bio-Rad customer form to be send to each customer. The letters identified the affected product and explained the reason for the recall. Customers were asked to examine their inventory and quarantine the affected lots listed. In addition, they are to complete and return the enclosed response form according to the instructions provided. Customers are contact their regional Bio-Rad office for Elution Buffer replacement.

Device

Device Recall Quantase Neonatal Elution Buffer
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers (PIN 532-5036)3250768, 32591735, 32592168, 32592634, 32500061, (PIN 532-5037) 32592456, 32592578, (PIN 532-5040) 32590518, 32590766, 32590915, 32591343, 32591734, 32592166, 32592632, 32500060
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including states of MI and MN and Bio-Rad facilities in Italy, France, Czech Republic, Canada, Argentina, Panama, United Kingdom, Hong Kong, China, Canada, Singapore, India, South Korea, Brazil, and Sweden.
  • 제품 설명
    Quantase Neonatal Elution Buffer, a component of Quantase Neonatal Accessory Kits (#1, 2 and 5), Model number 532-5035, included in 532-5036, 532-5037 and 532-5040, Manufactured by Bio-Rad Laboratories, Hercules, CA
  • Manufacturer
    Bio-Rad Laboratories Inc

Manufacturer

Bio-Rad Laboratories Inc
  • 제조사 주소
    Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
  • Source
    USFDA