Medical device manufacturer, Thermo Fisher Scientific, has issued a medical device safety alert concerning its B·R·A·H·M·S uE3 KRYPTOR with the following details:
The manufacturer has become aware about an underestimation of approximately 30% of uE3 concentration in patient samples when using the affected product. This effect was confirmed by its internal testing.
According to the manufacturer, the underestimation may lead to incorrect risk assessment for fetal chromosomal abnormalities. A patient may be considered at higher risk for fetal trisomy 21 and consequently additional or different treatment/investigation decisions need to be considered by the physician. The impact of an incorrect risk assessment is mitigated by the fact that uE3 measurement is not interpreted by its own but only in conjunction with other laboratory and clinical findings as advised by labeling.
The users are advised to take the following actions:
The manufacturer recommends a re-evaluation of the results that have been already generated with the affected lots
Product replacement is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 February 2019