Events

B·R·A·H·M·S Free ßhCG KRYPTOR 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 B·R·A·H·M·S GmbH 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
  • 날짜
    2016-02-24
  • 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
    Advice on action to be taken by the user: 1. All measured values generated with B·R·A·H·M·S Free βhCG KRYPTOR kit lot 09075 or 09073 can be used without any restrictions as long as value has been determined without dilution. 2. If you have samples that need to be diluted please use an unaffected lot. 3. B·R·A·H·M·S recommends that you re-evaluate the results that have been already generated in diluted samples/controls with B·R·A·H·M·S Free βhCG KRYPTOR kit lot 09075 or 09073. If possible please retest the samples with an unaffected kit lot. If you are in doubt about the result, especially for patients with a combined risk close to the cut- off(s) applied in your organization/country we recommend investigating further with the responsible clinician without delay. As a sub-recall to our action, we ask that you notify your customers of the field action. This notice contains a letter that you should use to contact your customers, or provide them with a translation. You are required to maintain records of all field actions and effectiveness checks. Newly produced B·R·A·H·M·S Free βhCG KRYPTOR kits (lot 09077) will be available as soon as possible. // FSCA ID: 02-16
  • 원인
    We have to inform you that we observe an overestimation of approximately 10% of free ßhcg concentration only in diluted samples or controls when using b·r·a·h·m·s free ßhcg kryptor kit lot 09075 or 09073. this may lead to incorrect risk estimation for fetal chromosomal abnormalities. a patient may be considered at higher risk for trisomy 21 or at lower risk for trisomy 13/18. as dilutions are only necessary in samples with very high concentration of free ßhcg it is anticipated that only a very small number of patients may be affected by such an error in risk assessment. however, the consequences of additional or different treatment/investigation decisions need to be considered.The impact of an incorrect risk results is mitigated by the fact that free ßhcg measurement is not interpreted by its own but only in conjunction with other laboratory and clinical findings as advised by labeling. the above also applies to cases, where b·r·a·h·m·s free ßhcg kryptor kit lot 09075 and 09073 is/was used as an aid in the diagnosis and follow up of trophoblast tumors of placental or testicular origin. all measurements of undiluted samples and controls remain unaffected and can be used as normal.

Device

B·R·A·H·M·S Free ßhCG KRYPTOR

Manufacturer

B·R·A·H·M·S GmbH
  • 제조사 주소
    B·R·A·H·M·S GmbH, Neuendorfstr. 25, 16761 Hennigsdorf/Germany
  • 제조사 모회사 (2017)
    Thermo Fisher Scientific Inc
  • Source
    AMPMDRS