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FDA issues ROM test alerts to health care providers

The FDA has issued a notice alerting health care providers that Qiagen Sciences' AmniSure ROM Test Strips, designed for amniotic fluid detection in pregnant women, was voluntarily recalled because of a possible manufacturing defect preventing display of the control line and posing a risk of test result misinterpretation. The agency also warned providers about the risks of serious adverse events, including fetal death, associated with "misuse, over-reliance and inaccurate interpretation" of results from use of ROM lab tests.

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