Filter-Tips — Class I medical device recall Z-2088-2019
Terminated recall by Qiagen Sciences LLC, reported 2019-08-07, distributed nationwide. Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsympho
| Recall number | Z-2088-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2019-06-05 |
| Classified | 2019-08-01 |
| Reported by FDA | 2019-08-07 |
| Terminated | 2020-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 1,240 kits |
| Reason classes | packaging |
| Lot numbers | 0605020019, 0605020020 |
| Model numbers | 9001297, 9001301, 997024 |
Product
Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation
Reason for recall
Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301)
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-2088-2019. 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.