# FDA recall Z-1636-2020

> **Qiagen Sciences LLC** · Class II · device recall initiated 2020-02-21.

## Product

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; 25 tests/box)

## Reason for recall

An image on the associated polybag contains an incorrect rinse time of 30 (thirty seconds). The correct rinse time is 1 (one) minute.

## Distribution

Nationwide domestic distribution. Foreign distribution to Canada.

## Key facts

- **Recall number:** Z-1636-2020
- **Recalling firm:** Qiagen Sciences LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-21
- **Report date:** 2020-04-08
- **Termination date:** 2020-10-05

- **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-1636-2020

## Citation

> AI Analytics. FDA recall Z-1636-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1636-2020. Source: US FDA. Licensed CC0.

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