QIAsymphony SP SOW 5 — Class II medical device recall Z-2319-2019
Ongoing recall by Qiagen Sciences LLC, reported 2019-08-28, distributed nationwide. QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the 2D bar code eluate ID to the sampl
| Recall number | Z-2319-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2019-07-02 |
| Classified | 2019-08-21 |
| Reported by FDA | 2019-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CN, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, IL, IN, IT, JO, JP, KR, KW, LV, MX, NL, NO, PK, PL, SE, SG, TH, TR, ZA |
| Quantity | 417 |
| Reason classes | software |
| Serial numbers | 10109, 10198, 10389, 10630, 11177, 11392, 11417, 11431, 11590, 11609, 11938, 12010, 12052, 12053, 12106, 12175, 12203, 12275, 12304, 12308, 12435, 12658, 12758, 12924, 12979 and 364 more |
| Model numbers | 9001297 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2319-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.