Events

Device Recall BC Phoenix AP 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Becton Dickinson & Co. 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
    78102
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0198-2018
  • 사례 시작날짜
    2017-06-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-05-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158667
  • 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
    Nephelometer, for clinical use - Product Code JQX
  • 원인
    Potential unexpected movement of robot arm.
  • 조치
    BD Diagnostic Systems telephoned all customers on June 1, 2017 and sent an Urgent Product Recall letter dated May 31, 2017, and Response Forms to their customers via email. BD recently confirmed a manufacturing issue with the motor that drives movement of the robot arm. The issue may result in the inability of this motor to withstand the lateral forces encountered during normal operations. Should this occur, the instrument will indicate an E20 error-Pipettor step loss during operation and stop functioning. While there is no loss of patient sample, the samples would need to be manually processed until the instrument can be repaired. To limit any disruption in the workload, BD Service will contact customers to schedule the instrument replacement. Customers are advised to complete and return the response form via email to BDRC2@aol.com. Customers may continue to use the instrument until replacement is performed. Customers with questions may contact BD (Customer/Technical) Support at 1-800-638-8663. For questions regarding this recall call 410-316-4258.

Device

Device Recall BC Phoenix AP
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: AP0447, AP0448, AP0449, AP0450, AP0451, AP0458 & AP0463.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including CA, NC & TN Internationally: Canada
  • 제품 설명
    BD PhoenixTM AP, Catalog Number 448010 || The BD Phoenix" AP instrument is designed for use with the BD Phoenix" system is intended to standardize ID broth tube inoculum, add AST indicator to the AST broth tube and transfer an aliquot of ID broth to AST broth tubes, as required for preparing samples for use on the BD Phoenix" system, which performs identification and susceptibility testing
  • Manufacturer
    Becton Dickinson & Co.

Manufacturer

Becton Dickinson & Co.