Safety alert on NADAL hCG Pregnancy Test with incorrect instructions for interpreting the results of pregnancy test

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10th December 2019 – (Hong Kong)  The Department of Health (DH) drew public attention to a safety alert concerning the NADAL hCG Pregnancy Test [Product Code: 141000, Lot/Batch: 169757, Expiry Date: 30 November 2020] manufactured by nal von minden GmbH, as incorrect instructions for interpreting results are shown on individual packaging.

The DH, through its routine surveillance on medical devices, noticed a safety alert issued by the Medicines and Healthcare Products Regulatory Agency of the United Kingdom. According to the alert, pregnancy test strips of batch 169757 are enclosed in individual packaging with incorrect instructions for interpreting the results of pregnancy test. This will produce an incorrect result (positive and negative results are reversed). 

A spokesman for the DH explained that incorrect results in the worst case can result in misdiagnosis and significant harm.

“The DH is following up to see if the affected products have been distributed in Hong Kong. Nevertheless, the public should be alerted as some of them may have obtained the product from abroad or from Internet purchase. The public is advised to stop using the concerned batch of the product and seek advice of healthcare professionals if in doubt,” the spokesman said.

So far, the DH has not received any local report of adverse incidents arising from use of the product.

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