Class I — Qiagen Sciences, Inc.
| Recalling firm | QIAGEN Sciences LLC |
|---|---|
| Registered facility | QIAGEN (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Potential for control line not appearing on the test strip |
| 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. |
| Quantity | 1620 kits |
| Distribution | Worldwide - US Nationwide distribution an in the country of , Canada |
| Initiated | 2018-05-18 |
| Classified | 2018-08-08 |
| Terminated | 2020-09-02 |
| Recall number | Z-2577-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Qiagen Sciences, Inc. (Z-2577-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80404/
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