Qiagen recalls software version 5.0.3 for QIAsymphony SP instruments due to potential incorrect patient reporting if 2D bar codes aren't verified before downstream applications. Affected units include specific serial numbers listed in the 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
Qiagen is recalling software version 5.0.3 for their QIAsymphony SP instruments. This software issue could lead to incorrect patient reporting if 2D bar code eluate IDs aren't checked against sample IDs before downstream applications. Using this software version without verification may cause delayed results or wrong patient information. Read more at govinfonow.com/recall/67510-qiagen-qiasymphony-sp-software-5-0-3-recall-risk-of.
“Qiagen QIAsymphony SP Software 5.0.3 Recall: Risk of Incorrect Patient Reporting.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67510-qiagen-qiasymphony-sp-software-5-0-3-recall-risk-of. Based on FDA recall #Z-2319-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2319-2019%22&limit=1).
Qiagen Sciences LLC recalled QIAsymphony SP SOW 5.0.3 software used with the QIAsymphony SP instrument because it may incorrectly assign bar code IDs, potentially leading to delayed results or incorrect patient reporting. The Food and Drug Administration announced the voluntary Class II recall on July 2, 2019.
How to tell if you have it
Brand: Qiagen
Product: QIAsymphony SP SOW 5.0.3
Model Number: 9001297
Units affected: 417
The hazard
The software issue incorrectly assigns the 2D bar code eluate ID to the sample within the results file. If these 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.
Context
GovInfoNow's records show Qiagen Sciences LLC has 16 other recalls on record since July 23, 2018. Other recent recalls of similar products include Qiagen QIAstat-Dx Respiratory Panel Plus (March 12, 2025), Qiagen QIAcube Connect MDx Recall (June 3, 2024), and Qiagen EZ2 Connect MDx-IVD Recall (March 4, 2024). Other recent recalls of similar products include Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026), GEM Premier 7000 with iQM3 (May 8, 2026), and Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026).
How to tell if you have this one
Check if your QIAsymphony SP instrument uses software version 5.0.3. Affected units have specific serial numbers listed in the recall notice, including 5786, 13184, and other numbers provided in the record.
Brand
Qiagen
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Verify Software Version
Check your QIAsymphony SP instrument's software version. If it is 5.0.3, you may need to update to a newer version.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 57 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2319-2019 (July 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2319-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.