# FDA recall Z-1891-2019

> **Qiagen Sciences, Inc.** · Class II · device recall initiated 2019-05-06.

## Product

RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from formalin-fixed, paraffin embedded (FFPE) tissues. The product is intended to be used by professional users, such as technicians and physicians that are trained in molecular biological techniques. It deploys an optimized silica spin-column-based protocol, and includes enzymatic removal of residual DNA. The RNeasy DSP FFPE Kit is intended for in vitro diagnostic use.

## Reason for recall

The deparaffinization solution contains a contaminant, which leads to reduced lysis efficiency of the affected lot, resulting in significantly reduced yields and less sensitive downstream applications.

## Distribution

US nationwide distribution in the states of  MA, RI, AZ, NY, NC, IN, TX.    The products were distributed to the following foreign countries:  Germany, Great Britain, Italy, France, Sweden, and Switzerland.

## Key facts

- **Recall number:** Z-1891-2019
- **Recalling firm:** Qiagen Sciences, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-06
- **Report date:** 2019-07-03
- **Termination date:** 2020-04-23

- **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-1891-2019

## Citation

> AI Analytics. FDA recall Z-1891-2019. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1891-2019. Source: US FDA. Licensed CC0.

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