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VITEK® 2 card pouches 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 bioMérieux 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • 데이터 추가 비고
  • 원인
    A potential issue was identified related to the white pouch which contains vitek® 2 test cards for the referenced product lots. biomérieux has determined that the integrity of some of the vitek® 2 test card pouches may be compromised. based on our investigation, a compromised test card pouch can impact card reagents due to the entry of moisture. the white pouch is composed of five (5) layers of material, four (4) of which are clear. all five layers must be compromised for a pouch to potentially allow moisture to enter the pouch. upon visual inspection of the pouch, you may notice a small puncture or tear in the packaging at the "stitch seal" (see figure a immediately below). per product labeling, do not use the card if the pouch (the white protective package cover) is damaged. based on internal testing, approximately 20% of card pouches exhibited a visual defect; the majority of card pouches with this visual defect maintained pouch integrity, i.E. at least one of the five material layers remained intact. however, 1 in 200 (0.5%) card pouches that passed careful visual inspection failed further integrity tests, indicating the potential for entry of moisture. .

Device

VITEK® 2 card pouches
  • 모델명 / 제조번호(시리얼번호)
    21341 GN ID Test Kit 20 Cards 2410047203 12-JAN-2018 413062 AST-N208 Test Kit 20 Cards 5780255103 08-AUG-18 414967 AST-YS07 Test Kit 20 Cards 2870221203 05-JUL-18
  • Manufacturer
    bioMérieux

Manufacturer

bioMérieux