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.
The software version 5.0.3 incorrectly assigns 2D bar code eluate IDs to samples in results files. If these IDs aren't checked against the actual sample IDs before downstream applications, the wrong tube could be selected, potentially leading to delayed results or incorrect patient reporting.
Professional users like technicians and physicians who operate the QIAsymphony SP instrument are likely affected. The risk is primarily for those using the software version 5.0.3 without verifying 2D bar codes against sample IDs.
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.
Check your QIAsymphony SP instrument's software version. If it is 5.0.3, you may need to update to a newer version.
The software version 5.0.3 for QIAsymphony SP instruments is being recalled.
Check your instrument's serial number against the list of affected serial numbers provided in the recall notice, which includes numbers like 5786, 13184, and others.
The recall does not specify a remedy, so you may need to update to a newer software version to avoid potential incorrect patient reporting.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-2319-2019 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-2319-2019 from Qiagen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
