FDA Device recall 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-inst…
- FDA Device
- Class I
- terminated
- Published 2018-08-15
On 2018-08-15 the FDA classified a Class I recall of 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-inst… by Qiagen Sciences, citing potential for control line not appearing on the test strip.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2577-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-05-18 |
| Published | 2018-08-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Qiagen Sciences |
| Distribution | US |
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.
Reason
Potential for control line not appearing on the test strip
Identifiers
| code_info | 1) UDI 14053228022319; Lot Numbers - 557016546, 557016547 & 5600115, Exp Date 7/28/2020 2) UDI 14053228022333; Lot Number - 557016409, Exp Date 7/28/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2577-2018%22
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