Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version:
FDA device recall Z-1504-2025 · posted 2025-03-31 · Open, Classified
Recall details
- Recalling firm
- Qiagen Sciences LLC
- Reason for recall
- Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
- Action taken
- 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 issue, above, to identify potentially erroneous diagnosis, except in those cases where alternative confirmation was obtained. o Review any result for which tests were performed, or treatments were given on clinical and/or epidemiological suspicion of the respective targets. 3. Review this notice with your laboratory/medical director. 4. Important: Forward this information to all individuals and departments within your organization using the above-listed kits. If you are not the end user, forward this notice to the product end user. 5. Complete the Acknowledgement of Receipt Form Actions taken by QIAGEN: QIAGEN was able to identify the root cause of the issue and has implemented immediate actions to ensure that the currently produced cartridges will not cause this issue moving forward. If you have any questions or concerns, please contact your local QIAGEN Technical Services Department through any of the following: Telephone: 800 362 7737; Email: TechService-NA@qiagen.com
- Root cause
- Mixed-up of materials/components
- Status
- Open, Classified
- Product code
- QOF
- Quantity affected
- 445 units
- Distribution
- US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX.
- Date initiated
- 2025-03-12
- Date posted
- 2025-03-31
- Location
- Germantown, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QIAstat-Dx® Respiratory Panel Plus (K233100) | QIAGEN GmbH | 2024-05-10 |