Qiagen Sciences, Inc. recalls AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Us…

Recall date

May 18, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2577-2018

FDA classification

Class I

Brand / firm

Qiagen Sciences, Inc.

Sold / distributed

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

Why it was recalled

Potential for control line not appearing on the test strip

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.