Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAs...
FDA Device Recall #Z-2088-2019 — Class I — June 5, 2019
Recall Summary
| Recall Number | Z-2088-2019 |
| Classification | Class I — Serious risk |
| Date Initiated | June 5, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Qiagen Sciences LLC |
| Location | Germantown, MD |
| Product Type | Devices |
| Quantity | 1240 Kits |
Product Description
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)
Distribution Pattern
US Nationwide distribution
Lot / Code Information
Lot Numbers: 0605020019 and 0605020020
Other Recalls from Qiagen Sciences LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1504-2025 | Class II | Brand Name: QIAstat-Dx Product Name: QIAstat-D... | Mar 12, 2025 |
| Z-2353-2024 | Class II | QIAcube Connect MDx - IVD Instrument designed t... | Jun 3, 2024 |
| Z-1508-2024 | Class II | EZ2 Connect MDx-IVD Designed to perform automat... | Mar 4, 2024 |
| Z-1683-2023 | Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel multipl... | Apr 28, 2023 |
| Z-1652-2022 | Class II | FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010 | Jul 20, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.