Events

Model BP7507 OPTI LION EPlus Cassette 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 OPTI Medical Systems, 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
    66105
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0029-2014
  • 사례 시작날짜
    2013-08-09
  • 사례 출판 날짜
    2013-10-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-12-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121489
  • 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
    Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
  • 원인
    Opti lion e-plus cassettes were labeled with an incorrect barcode. the incorrect barcode could perfect the performance of one or more parameters as the product ages. also a customer complaint from a distributor reported that a customer was getting qc failures.
  • 조치
    The firm, OPTIMedical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 9, 2013 via email and fax to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the product; return any unused product to OPTI Medical System; distributors outside the U.S. may destroy unused product and certify the instructions on the enclosed Recall Response Card; contact your distributor or OPTI Medical System Technical Support at 1-800-490-6784 or technicalsupport@optimedical.com to obtain authorization number and shipping instructions; and complete and return the Recall Response Card to technical support via fax to 1-770-510-4447; mail to: OPTI Medical Technical Support, OPTI Medical Systems, Inc., 235 Hembree Park Drive, Roswell, GA 30076 or email: technicalsupport@optimedical.com Please contact OPTI Medical Systems, Technical Support department at 1-800-490-6784 if you have questions related to this notice.

Device

Model BP7507 OPTI LION EPlus Cassette
  • 모델명 / 제조번호(시리얼번호)
    Lots 252810, 315815, 319810, 319815, 321817, 367812, 370812
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US (nationwide) including states of: CA, MA, MN, and VA; and countries of: China, Guatemala, India, Iraq, South Korea, and Untied Arab Emirates.
  • 제품 설명
    Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical || Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.
  • Manufacturer
    OPTI Medical Systems, Inc

Manufacturer

OPTI Medical Systems, Inc
  • 제조사 주소
    OPTI Medical Systems, Inc, 235 Hembree Park Dr, Roswell GA 30076-5738
  • 제조사 모회사 (2017)
    IDEXX Laboratories, Inc.
  • Source
    USFDA