Reported Aug 28, 2019 · Ongoing
QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed…
Qiagen Sciences LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qiagen Sciences LLC · 19300 Germantown Rd · Germantown, MD · 20874-1415
Is this the product you have?
- 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 Number9001297
- Product UsageThe 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
- Lot codes and dates
- Software 5.0.3
- Serial Numbers
389 of 389 codes
5786131843000034450348863521435455355105943131953402334457348873522235456355146037132753404034464348913522435457355196263134863404534468348923522635458355226325135923406834473348933523135459355246529136353490734477348943524135460355256531136403408034495348963524535462355266828136483408134496
- Amount recalled
- 417
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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