Recall Z-2319-2019— Qiagen Sciences LLC

Class II FDA medical device recall by Qiagen Sciences LLC, initiated 2019-07-02. FDA's recall record names no specific 510(k) clearance for this event. 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: 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.

Recalling firm

Qiagen Sciences LLC

Classification

Class II

Status

Ongoing

Initiated

2019-07-02

Firm location

Germantown, MD, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.