Immunoassay For Detection Of Amniotic Fluid Protein(s).
Clinical Chemistry · 21 CFR 862.1550
The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture.
Recent MDR events
41 adverse event reports on file
- AmnisureJul 28, 2026MalfunctionQiagen Sciences Llc50053835
- AMNISURE ROM TESTMar 24, 2025MalfunctionQiagen Sciences, Inc.21676064
- AMNISURE ROM TESTAug 30, 2024DeathQiagen Sciences, Llc1122376-2024-00002
- AMNISURENov 18, 2022MalfunctionQiagenMW5113380
- AMNISURE ROM TESTFeb 24, 2020MalfunctionQiagen Sciences, Llc1122376-2020-00005
- AMNISURE ROM TESTFeb 24, 2020MalfunctionQiagen Sciences, Llc1122376-2020-00004
- AMNISURE ROM TESTFeb 19, 2020MalfunctionQiagen Sciences, Llc1122376-2020-00003
- AMNISURE ROM TESTFeb 19, 2020MalfunctionQiagen Sciences, Llc1122376-2020-00002
- AMNISURE ROM TESTFeb 19, 2020MalfunctionQiagen Sciences, Llc1122376-2020-00001
- AMNISURE RAPID FETAL MEMBRANES RUPTURE TESTOct 21, 2019MalfunctionQiagenMW5090539
Event type breakdown
Recalls
3 recall events for this product code
- Qiagen Sciences, Inc.TerminatedJul 13, 2018
AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA
Potential for control line not appearing on the test strip
Z-2577-2018 · View FDA record ↗ - Clinical Innovations, LLCTerminatedUnknown
Clinical Innovations ROM Plus Collection Kit
Possible false negative or false positive results. The incorrect sample collection swabs (non-scored) were assembled into assembled into the in vitro diagnostic kits. If the user does not break the swab stick correctly, or if scissors or other tools are used to cut the swab handle false negative or false positive results can occur.
Z-0541-2021 · View FDA record ↗ - Qiagen Sciences LLCTerminatedUnknown
AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution
An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.
Z-1636-2020 · View FDA record ↗
Registered firms
6 firms currently registered for this product code
510(k) clearances
2 clearances for this product code