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Medical Devices / Regulatory Affairs

MHRA Recalls Digital Pregnancy Tests

Oct. 18, 2018
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The UK’s Medicines and Healthcare products Regulatory Agency Issued a recall for Wondfo Clear & Simple digital pregnancy tests due to a number of false positive results from the tests manufactured by the Guangzhou, China-based company.

Wondfo reported that some of the test kits could deliver false readings, attributing the problem to a large gap between the test strip bracket and the plastic enclosure of the test kit that allowed a change in light to affect the tests.

The recall affected one lot involving 58,000 tests distributed in the UK, according to the MHRA.

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