FDAFDA · Food and drugs·Recall number Z-2577-2018
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.
Published August 15, 2018 · Recall initiated: May 18, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for control line not appearing on the test strip
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Qiagen Sciences, Inc.
- Distributor
- Worldwide - US Nationwide distribution an in the country of , Canada
- Lot
- 1) UDI 14053228022319; Lot Numbers - 557016546, 557016547 & 5600115, Exp Date 7/28/2020 2) UDI 14053228022333; Lot Number - 557016409, Exp Date 7/28/2020
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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