Device recall
Z-2577-2018: AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2)…
FDA device recall · Class I · Qiagen Sciences, Inc.
Key facts
| Recall number (Z-number) | Z-2577-2018 |
|---|---|
| Recall event | 80404 |
| 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. |
| Product code | NQM |
| Recalling firm | Qiagen Sciences, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 2, 2020 |
| 510(k) numbers | K081767 |
| FEI number | 3003572099 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database