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.
FDA issues ROM test alerts to health care providers
Sign up for AdvaMed SmartBrief
Medical technology news
Get the intelligence you need: news and information that is changing your industry today, hand-curated by our professional editors from thousands of sources and delivered straight to your inbox.