# FDA recall Z-2319-2019

> **Qiagen Sciences LLC** · Class II · device recall initiated 2019-07-02.

## Product

QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD)  Model Number: 9001297    Product Usage:  The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids. It is intended to be used only in combination with QIAsymphony kits indicated for use with the QIAsymphony SP for the applications described in the kit handbooks. The QIAsymphony SP is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the QIAsymphony SP instrument

## Reason for recall

QIAsymphony software version 5.0.3 - Software issue  incorreclty assigns the 2D bar code eluate ID to the sample within the results file. If 2D bar code eluate IDs are not checked against the sample ID prior to downstream  application the incorrect tube may be selected and it could have the potential to lead to delayed results or incorrect patient reporting

## Distribution

Worldwide Distribution - US Nationwide  Foreign:  Algeria  Australia  Austria  Azerbaijan  Belgium  Brazil  Canada  China  Czech Republic  Denmark  Finland  France  Germany  Greece  India  Israel  Italy  Japan  Jordan  Korea, Republic of  Kuwait  Latvia  Mexico  Netherlands  Norway  Pakistan  Poland  Republic of Korea  Russian Federation  Singapore  South Africa  Spain  Sweden  Switzerland  Thailand  Turkey  United Kingdom

## Key facts

- **Recall number:** Z-2319-2019
- **Recalling firm:** Qiagen Sciences LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-07-02
- **Report date:** 2019-08-28

- **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-2319-2019

## Citation

> AI Analytics. FDA recall Z-2319-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2319-2019. Source: US FDA. Licensed CC0.

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