PlainRecalls
FDA Devices Moderate Class II Ongoing

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 inten

Reported: August 28, 2019 Initiated: July 2, 2019 #Z-2319-2019

Product Description

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

Details

Recalling Firm
Qiagen Sciences LLC
Units Affected
417
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
Location
Germantown, MD

Frequently Asked Questions

What product was recalled? ▼
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. Recalled by Qiagen Sciences LLC. Units affected: 417.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2019. Severity: Moderate. Recall number: Z-2319-2019.

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