Events

Device Recall API Listeria (REF 10300)) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Biomerieux France Chemin De L'Or 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
    66931
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0842-2014
  • 사례 시작날짜
    2013-11-08
  • 사례 출판 날짜
    2014-01-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-11-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124231
  • 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
  • 원인
    Biom¿rieux identified a visual defect and activity issue on the zym b reagent (ref 70493); leading to a false negative results of some api biochemical tests using the zym b reagent.
  • 조치
    bioMerieux sent an Urgent Product Removal Notice letter dated November 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure the letter and guidance were distributed and received by all appropriate personnel in their organization, customers were instructed to discontinue use and destroy ZYM (B 70493), API NH (10400) API Listeria (10300) with ZYM B ampules having a visual defect. Customers still in possession of some kits of ZYM B (70493-Lots: 1) without visual defect that is used with API 20 Strep (20600), API Coryne (20900), API Staph (20500) and API ZYM (25200), have the option to: a) Use the kits of ZYM B (70493) still in your inventory with the following mandatory requirement for the API Strep and API Coryne: perform a daily quality control with the ATCC¿ strain described in the paragraph Reading and Interpretation of the package insert of each API strip prior to using the ZYM B ampules. b) Use the kits of ZYM B (70493) still in your inventory without any requirement with API Staph and API ZYM, or c) Discard all kits of ZYM B (70493) still in their inventory. If you are still in possession of some kits of API NH (10400-Lots: See Annex 1) without visual defect of ZYM B, you have the option to: a) Use the kits of API NH (10400) still in your inventory with the mandatory requirement: perform a daily quality control with the ATCC¿ strain 49917 Haemophilus paraphrophilus described in the paragraph Use of the reagents of the package insert of API NH prior to using the ZYM B ampules or, b) Discard all the kits of API NH (10400) still in your inventory. 5. If you are still in possession of some kits of API Listeria (10300-Lots: See Annex 1) without visual defect of ZYM B, we ask you to use the API Listeria (10300) still in your inventory with the mandatory requirement: perform a daily quality control with the ATCC¿ strain 33090 Listeria innocua as

Device

Device Recall API Listeria (REF 10300))
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 1002210010, 1002210011, 1002287930, 1002287931, 1002350760, 1002390940, 1002390941, 1002518070, 1002518071, 1002518072, 1001915090, 1001915091, 1001915092, 1001932340, 1001998120 and 1002129350.
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to U.S. Nationwide; Algerie, Argentina, Armenia, Australia, Austria, Azerbaidjian, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bolivia, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chad, Chile, China, Colombia, Democratic Republic of Congo, Costa Rica, Cote d'Ivorie, Germany, Czech Republic, Dominican Republic, Dutch Antilles, Dutch Antilles, Ecuador, Egypt, Republica De El Salvador, Estonia, Germany, Ethiopia, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Germany, Indonesia, Iraq, Israel, Italy, Jamaica, Japan, Iraq, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malaysia, Malaysia, Mali, Malta, Mexico, Romania, Mongolia, Morocco, Mozambique, Singapore, Netherlands, Managua, Niamey Niger, Nigeria, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Uganda, Kingdom of Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Tanzania, Italy, Thailand, Trinidad & Tobago, Tunisia, Turkey, Uganda, Ukraine, UAE, United Kingdom, Uruguay, Venezuela, Vietnam, Vietnam, Yemen and Zimbabwe
  • 제품 설명
    API Listeria (REF 10300) || API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in the API Listeria strips. ZYM B reagent is added in the DIM test before reading miniaturized biochemical test including in the API Listeria strips.
  • Manufacturer
    Biomerieux France Chemin De L'Or

Manufacturer

Biomerieux France Chemin De L'Or
  • 제조사 주소
    Biomerieux France Chemin De L'Or, Chemin De L'Orme, Marcy L'Etoile France
  • 제조사 모회사 (2017)
    Compagnie Merieux Alliance
  • Source
    USFDA