EZ1 Advanced XL — Class II medical device recall Z-0383-2019
Terminated recall by Qiagen Sciences LLC, reported 2018-11-14, distributed nationwide. An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trig
| Recall number | Z-0383-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2018-07-23 |
| Classified | 2018-11-03 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2020-06-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, CA, CH, CN, DE, EG, ES, FR, GB, GR, HU, IN, IT, JO, JP, KR, LV, MA, MX, NO, QA, RU, SA, SE, SG, SI, TN, TR |
| Quantity | 298 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04053228010760 |
| Model numbers | 9001492 |
Product
EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1 Advanced XL instrument for the applications described in the kit handbooks. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ1 Advanced XL.
Reason for recall
An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. If this failure were to occur, nucleic acid extractions could be compromised and extractions need to be repeated. This could cause a delay in obtaining results from downstream applications.
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-0383-2019. 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.