Qiagen QIAsymphony SP Software 5.0.3 Recalled for Barcode Assignment Error
Qiagen is recalling QIAsymphony SP software version 5.0.3 because it incorrectly assigns 2D barcode eluate IDs to samples, which could lead to incorrect patient reporting.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that could lead to incorrect patient reporting, a risk-of-harm scenario where specific injuries or illnesses have not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Qiagen Sciences LLC is recalling QIAsymphony SP software version 5.0.3, which is used with the QIAsymphony SP Instrument for the automated purification of nucleic acids. The recall involves 417 units distributed worldwide, including in the United States and numerous foreign countries.
The software contains a defect where it incorrectly assigns the 2D barcode eluate ID to the sample within the results file. If these IDs are not manually checked against the sample ID before downstream application, the incorrect tube may be selected. This error has the potential to lead to delayed results or incorrect patient reporting.
The QIAsymphony SP instrument is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques. Users should verify their software version and contact the manufacturer for instructions on how to resolve the issue.
The recalled product
- 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…
- Manufacturer
- Qiagen Sciences LLC
- Affected units
- 417
Distribution
Distributed nationwide across the United States.
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