CDRHNew - News and Updates

CDRHNew - News and Updates

The following new items were added to the CDRH web pages on August 8, 2018. Previous CDRH New items can be found on the CDRH New webpage. Qiagen Sciences LLC. Recalls the AmniSure ROM Test Due to Lack of Control Line- Which May Lead to Misinterpretation of Test Results Risks Associated with Use of Rupture of Membranes Tests - Letter to Health Care Providers FDA Press Release – FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests