Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): ...
FDA Device Recall #Z-1504-2025 — Class II — March 12, 2025
Recall Summary
| Recall Number | Z-1504-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 12, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Qiagen Sciences LLC |
| Location | Germantown, MD |
| Product Type | Devices |
| Quantity | 445 units |
Product Description
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.
Distribution Pattern
US Distribution: AL, CA, DC, FL, IN, KS, KY, MA, ME, MN, NY, and TX.
Lot / Code Information
REF 691224; Lot 178038604; UDI-DI: 04053228047438; affected Serial numbers (SNs): 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 332169041 332169042 332169047 332169048 332169049 332169050 332169055 332169056 332169057 332169060 332169065 332169066 332169073 332169074 332169083 332169084 332169085 332169086 332169091 332169092 332169093 332169094 332169099 332169101 332169102 332169107 332169108 332169109 332169110 332169115 332169116 332169117 332169118 332169123 332169125 332169126 332169131 332169132 332169133 332169134 332169139 332169140 332169141 332169142 332169147 332169148 332169149 332169150 332169155 332169156 332169157 332169158 332169163 332169164 332169165 332169166 332169171 332169172 332169173 332169174 332169180 332169181 332169182 332169187 332169188 332169189 332169190 332169195 332169196 332169197 332169198 332169203 332169204 332169205 332169206 332169212 332169213 332169214 332169216 332169221 332169222 332169223 332169224 332169229 332169230 332169231 332169232 332169238 332169239 332169240 332169241 332169246 332169247 332169248 332169249 332169255 332169256 332169257 332169262 332169263 332169264 332169265 332169271 332169272 332169273 332169279 332169280 332169282 332169287 332169288 332169289 332169290 332169295 332169296 332169297 332169298 332169303 332169315 332169320 332169321 332169322 332169323 332169328 332169329 332169330 332169331 332169336 332169337 332169338 332169339 332169344 332169345 332169346 332169347 332169354 332169355 332169360 332169361 332169362 332169365 332169368 332169369 332169370 332169371 332169376 332169377 332169378 332169379 332169384 332169385 332169386 332169387 332169392 332169393 332169394 332169395 332169401 332169403 332169410 332169412 332169413 332169418 332169420 332169427 332169428 332169429 332169434 332169442 332169443 332169460 332169475 332169477 332169483 332169484 332169486
Other Recalls from Qiagen Sciences LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| 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 |
| Z-1651-2022 | Class II | therascreen FGFR RGQ RT-PCR Kit (CE IVD, not so... | 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.