AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women.

Reason: Potential for control line not appearing on the test strip

Code information: 1) UDI 14053228022319; Lot Numbers - 557016546, 557016547 & 5600115, Exp Date 7/28/2020 2) UDI 14053228022333; Lot Number - 557016409, Exp Date 7/28/2020

Distribution pattern: Worldwide - US Nationwide distribution an in the country of , Canada