# FDA recall Z-2577-2018

> **Qiagen Sciences, Inc.** · Class I · device recall initiated 2018-05-18.

## 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 for recall

Potential for control line not appearing on the test strip

## Distribution

Worldwide - US Nationwide distribution an in the country of , Canada

## Key facts

- **Recall number:** Z-2577-2018
- **Recalling firm:** Qiagen Sciences, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-05-18
- **Report date:** 2018-08-15
- **Termination date:** 2020-09-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Germantown, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2577-2018

## Citation

> AI Analytics. FDA recall Z-2577-2018. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2577-2018. Source: US FDA. Licensed CC0.

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