Device Recall Biomerieux 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 BioMerieux SA 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
    80111
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2170-2018
  • 사례 시작날짜
    2018-03-23
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Slide stainer, automated - Product Code KPA
  • 원인
    A shipment to guadeloupe suffered a temperature excursions up to 47.8¿c, exceeding the acceptable limits. after detection of the issue, global supply chain qa asked the biom¿rieux distributor in guadeloupe to put products in quarantine in july 2017; after several reminders, the distributor informed in november 2017 that products were delivered to customers.
  • 조치
    The firm, Biomerieux, sent an "Urgent product removal notice" letter on April 23 to affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Immediately acknowledge receipt (AR) of this FSCA. 2. Identify all countries and customers for which you are responsible that are impacted by this FSCA. 3. Define additional actions required (e.g. Translate customer letter, send to impacted countries/customers, etc.) 4. Distribute the customer letter to all customers that have received the products 5. Discard any impacted product remaining in local inventory 6. After all actions above are complete, please return the acknowledgement of completion (AC) for this FSCA. The due date for completion of the required actions and submitting the AC is 23-APR-2018 Subsidiaries ¿ Subsidiaries using SAP, please manage both the Acknowledgment of Receipt and the Acknowledgment of Completion of activities in SAP. ¿ Subsidiaries not using SAP, please immediately upload the Acknowledgement of Receipt in LiveLink after signing and completing sections #1 and #2. Section #3 must be signed, completed and uploaded in LiveLink before the due date. Distributors ¿ Please immediately Acknowledge Receipt of this FSCA by completing sections #1 and #2 of the acknowledgement form and sending it by email to fieldactions@biomerieux.com or by fax to +33 4 78 87 21 79. Please remember to sign and complete all of sections #1 and #2. ¿ Sections #1 and #3 must be signed, completed, faxed or emailed before the due date. If you have any questions, contact the Specialist, Regulatory & Quality Compliance at +33 4 78 87 56 16 or email to: charlotte.thollet@ext.biomerieux.com.

Device

  • 모델명 / 제조번호(시리얼번호)
    Reagents for use with the PREVI¿ Color Gram:  IODINE-B (ref: 29523) Lot number: G59407 Exp. 15-Aug-18 CRYSTAL VIOLET-C (ref: 29524) Lot number: G52306 Exp.19-Jul-18 FUCHSIN-A (ref: 29522): Lot Number Lot number: F89544 Exp. 13-Apr-18
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    International distribution.
  • 제품 설명
    The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. || The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have been smeared with specimens to be examined. The staining procedure is rapid and precise. Each reagent has a specific position (A, B, C, D, E) on the PREVI¿ Color Gram platform that is also indicated on the reagent label. || An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.
  • Manufacturer

Manufacturer

  • 제조사 주소
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • 제조사 모회사 (2017)
  • Source
    USFDA