The Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom has posted a medical device safety alert concerning NADAL hCG Pregnancy rapid test [Item number: 142002; Lot numbers: All], manufactured by nal von minden GmbH.
This safety notice concerns the limitations of the NADAL hCG Pregnancy rapid test, which is calibrated for intact hCG and detects intact hCG only.
The proportions of intact hCG and other hCG forms in serum and urine may differ according to the stage of pregnancy in which it is analysed. According to the manufacturer, in rare cases, at a more advanced stage of pregnancy (approximately week 5-8 of pregnancy), increased amounts of hCG-beta-core fragments may be present in the urine hindering the detection reaction and leading to false negative results in spite of high hCG concentration.
Customers are advised to pay attention to this further limitation when evaluating the test result.
For details, please refer to the MHRA website:
https://www.gov.uk/drug-device-alerts/field-safety-notices-19-december-23-december-2016
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 January 2017