Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel… — Class II medical device recall Z-1504-2025
Ongoing recall by Qiagen Sciences LLC, reported 2025-04-09, distributed in AL, CA, DC, FL, IN, KS, KY, MA…. Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could
| Recall number | Z-1504-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qiagen Sciences LLC, Germantown, MD, United States |
| Recall initiated | 2025-03-12 |
| Classified | 2025-03-31 |
| Reported by FDA | 2025-04-09 |
| Distributed | AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, TX |
| Quantity | 445 units |
| UPC / GTIN / UDI-DI | 04053228047438 |
| Lot numbers | 178038604 |
| Serial numbers | 332168961, 332168962, 332168963, 332168964, 332168972, 332168978, 332168979, 332168980, 332168990, 332168996, 332169005, 332169012, 332169013, 332169015, 332169016, 332169021, 332169022, 332169023, 332169024, 332169031, 332169032, 332169033, 332169034, 332169039, 332169040 and 175 more |
| Model numbers | 691224 |
Product
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Reason for recall
Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
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-1504-2025. 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.