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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
Recalled August 15, 2018 · FDA recall Z-2577-2018 · Qiagen Sciences
Hazard
Potential for control line not appearing on the test strip · FDA Class I
Units
1620 kits
Sold at
Worldwide - US Nationwide distribution an in the country of , Canada
Description
Potential for control line not appearing on the test strip
Product
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.
Manufacturer(s)
Qiagen Sciences, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →