QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of ...
FDA Device Recall #Z-2353-2024 — Class II — June 3, 2024
Recall Summary
| Recall Number | Z-2353-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 3, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Qiagen Sciences LLC |
| Location | Germantown, MD |
| Product Type | Devices |
| Quantity | 419 units |
Product Description
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1
Reason for Recall
Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when running IVD protocol QIAamp¿ DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria (Script filename: Kt_name_Bacteria (Gram+) or rY'east_Enzymatic Lysis_ V2) which could potentially cause delayed or erroneous results depending on the downstream assay.
Distribution Pattern
Nationwide. Foreign: AD, AT, AU, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, ID, IN, IT, JO, KR, KZ, LU, ML, MY, NL, NO, PH, PL, PY, SA, SE, SG, SK, SO, VN J, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI
Lot / Code Information
GTIN 04053228039129 ALL serial numbers shipped to date. SN 30000-30506 is the impacted range (later serial numbers and units in QIAGEN warehouses will include supplemental instructions for operating the heater in protocols requiring incubation temperatures of 40C or lower prior to shipment)
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-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 |
| Z-1650-2022 | Class II | therascreen FGFR RGQ RT-PCR kit (US IVD) REF 8... | 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.