Events

Barbiturate Enzyme Immunoassay 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Lin-Zhi International 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
    60750
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0846-2012
  • 사례 시작날짜
    2011-09-08
  • 사례 출판 날짜
    2012-01-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-01-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106392
  • 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
    Enzyme immunoassay, barbiturate - Product Code DIS
  • 원인
    Catalog #0140 and 0141 barbiturate eia small and large kits were not correctly made to specification such that the two antibodies used in production did not have curves that correctly aligned.
  • 조치
    Lin-Zhi sent a letter via e-mail dated September 8, 2011 to customers with information regarding the recall. The e-mail identified the product description, lot number, description of nonconformity and corrective actions to be taken. Each customer and distributor was then contacted by regulatory affairs personnel by phone on September 9, 2011 or September 12, 2011. Customers and distributors were contacted to determined whether they wanted a replacement of the affected product. Customers that wished for replacements of the affected product was asked to correctly dispose of the product with the lot numbers listed. For questions or concern call 408-732-3856.

Device

Barbiturate Enzyme Immunoassay
  • 모델명 / 제조번호(시리얼번호)
    Large Kits Catalog number 0141, lot # 1105052, exp 11/25/12; small kits catalog number 0140, lot # 1105053, exp 11/25/12.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) including the states of: AL, CA, FL, IN, MA, NC, NH, TX and the countries of: Germany and United Kingdom.
  • 제품 설명
    Barbiturate Enzyme Immunoassay; R1 || Antibody/Substrate Reagent (5000 tests and 500 tests); || Contains a mixture of monoclonal and polyclonal anti-barbiturate antibody, glucose 6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD), stabilizers, and with sodium azide as preservative. || and Barbiturate Enzyme Immunoassay R2; || Enzyme Conjugate Reagent (5000 tests and 500 test packaging); || Contains glucose-6-phosphate dehydrogenase (G6PDH) labelled with barbiturate in buffer with sodium azide as preservative. || For in-vitro diagnostic use only. || Lin-Zhi International Inc. || 670 Almanor Ave., || Sunnyvale, CA 94085 || Product Usage: Drug testing
  • Manufacturer
    Lin-Zhi International Inc

Manufacturer

Lin-Zhi International Inc
  • 제조사 주소
    Lin-Zhi International Inc, 670 Almanor Ave, Sunnyvale CA 94085-3513
  • 제조사 모회사 (2017)
    Lin-Zhi International Inc.
  • Source
    USFDA