Recall Z-1504-2025 · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Qiagen Sciences LLC
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
| Date | Mar 31, 2025 (initiated Mar 12, 2025) |
| Status | Open, Classified |
| Reason | Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur. |
| Root cause | Mixed-up of materials/components |
| Action | On March 12, 2025, "URGENT MEDICAL DEVICE CORRECTION" letters were sent to customers. Actions to be taken by customer/user: 1. Check if you have remaining stock. DO NOT use it. Dispose of it immediately in accordance with your national and local safety and environmental regulations. 2. Contact QIAGEN Technical Services for a free-of-charge replacement. o If you already used cartridges from this LOT, identify the results obtained with cartridges from the affected SN. For results obtained with an affected SN: Review all results of the respective targets mentioned in Detailed description of the i |
| Quantity | 445 units |
| Distribution | US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233100 | QIAstat-Dx® Respiratory Panel Plus QIAGEN GmbH, May 10, 2024 |