Events

Field Safety Notices about B·R·A·H·M·S Free ßhCG KRYPTOR

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by B·R·A·H·M·S GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-02-24
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
    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
  • Reason
    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
  • Manufacturer Address
    B·R·A·H·M·S GmbH, Neuendorfstr. 25, 16761 Hennigsdorf/Germany
  • Manufacturer Parent Company (2017)
    Thermo Fisher Scientific Inc
  • Source
    AMPMDRS