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NEW YORK (360Dx) – The US Food and Drug Administration said on Wednesday that Qiagen Sciences is recalling the AmniSure ROM Test due to a manufacturing defect that causes the control line to not display.

The agency also said it has alerted women and their doctors about serious adverse events related to the improper use of these types of tests, which are called rupture of membranes tests.

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Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.