FDA Device recall Z-2319-2019
QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated…
- FDA Device
- Class II
- ongoing
- Published 2019-08-28
On 2019-08-28 the FDA classified a Class II recall of QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated… by Qiagen Sciences, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2319-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-07-02 |
| Published | 2019-08-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Qiagen Sciences |
| Distribution | US |
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
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
Identifiers
| code_info | Software 5.0.3 Serial Numbers: 5786 13184 30000 34450 34886 35214 35455 35510 5943 13195 34023 34457 34887 35222 354…Software 5.0.3 Serial Numbers: 5786 13184 30000 34450 34886 35214 35455 35510 5943 13195 34023 34457 34887 35222 35456 35514 6037 13275 34040 34464 34891 35224 35457 35519 6263 13486 34045 34468 34892 35226 35458 35522 6325 13592 34068 34473 34893 35231 35459 35524 6529 13635 34907 34477 34894 35241 35460 35525 6531 13640 34080 34495 34896 35245 35462 35526 6828 13648 34081 34496 34897 35259 35463 35529 7188 13654 34083 34504 34901 35265 35464 35530 7232 13755 34086 34507 34902 35278 35465 35532 7295 13773 34112 34525 34701 35279 35466 35537 7297 13777 34116 34555 34914 35287 35467 35538 7340 13797 34123 34557 34923 35312 35468 35542 7349 13813 34124 34562 34931 35322 35469 35544 7409 13841 34129 34567 34951 35335 35471 35545 7432 13858 34143 34571 34977 35338 35472 35547 7480 13862 34152 34580 34981 35344 35473 35548 7725 13874 34153 34582 34986 35352 35474 35549 7973 13886 34161 34588 34988 35360 35475 35550 8049 13904 34181 34589 34366 34076 35476 35557 8052 13 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2319-2019%22
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