Reported Aug 15, 2018 · Terminated
AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product…
Qiagen Sciences, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qiagen Sciences, Inc. · 19300 Germantown Rd · Germantown, MD · 20874-1415
Is this the product you have?
- AmniSure
- ROM Test under the following labels1) Catalog Number FMRT-1-25 and 2) Catalog
- Number FMRT-1-25-CA Product UsageRapid, non-instrumented, qualitative immunochromatographic test for the in vitro detection of amniotic fluid in vaginal discharge of pregnant women
- Lot codes and dates
1) UDI 14053228022319Lot Numbers - 557016546557016547 & 5600115Exp Date 7/28/2020 2) UDI 14053228022333Lot Number - 557016409Exp Date 7/28/2020
- Amount recalled
- 1620 kits
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Potential for control line not appearing on the test strip
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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