Attn: Clinical Laboratories and Health Care Providers

FYI / AmniSure ROM Test Recall and Adverse Events

The Food and Drug Administration (FDA) recently issued a news release about serious adverse events related to the improper use of tests intended as an aid in detecting if a pregnant woman’s water has broken (also known as a rupture of the membranes containing amniotic fluid).

This follows the Qiagen Sciences LLC recall of the AmniSure ROM Test due to a potential manufacturing defect causing the control line to not display. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.