Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 28, 2019
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
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Qiagen Sciences LLC recalled QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsympho… - a moderate-severity action.
QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsympho… was recalled by Qiagen Sciences LLC in August 28, 2019. Reason: QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate ID to the sam…. Check the official notice for the remedy. Verify recall #Z-2319-2019 with the FDA Devices before acting.
The recall
Qiagen Sciences LLC issued this moderate-severity FDA Devices recall-QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate ID to the sam….
- Moderate
- severity level
- 417 units
- affected scope
- Class II
- classification
- August 28, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2319-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2319-2019) was formally reported on August 28, 2019, with the manufacturer initiating the action on July 2, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Qiagen Sciences LLC is listed as the recalling firm, operating out of Germantown, MD. Federal records list the affected scope as 417.
The documented reason for this recall is: 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 downstre… Distribution data in the federal record shows the product reached: 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 …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
417
Related Recalls
6
3 from same agency
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2319-2019 |
| Date reported | August 28, 2019 |
| Date initiated | July 2, 2019 |
| Recalling firm | Qiagen Sciences LLC |
| Firm location | Germantown, MD |
| Affected scope | 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 … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2319-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2319-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 28, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.