Qiagen Sciences LLC recalls
Every recall we track for Qiagen Sciences LLC — 20 in all, from 2018–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
20 recalls since 2017.
All FDA recall records for Qiagen Sciences LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 1 | 0 | 1 |
| 2019 | 0 | 0 | 2 | 0 | 2 |
| 2020 | 0 | 0 | 5 | 0 | 5 |
| 2021 | 0 | 0 | 3 | 0 | 3 |
| 2022 | 0 | 0 | 5 | 0 | 5 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 2 | 0 | 2 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Qiagen Sciences LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Qiagen Sciences LLC recalls
17 shown- Lower riskMedical device
Qiagen Sciences LLC recalls Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version:
Qiagen recalls QIAstat-Dx Respiratory Panel Plus cartridges with serial numbers listed. Faulty cartridges may cause false test results if used for sample testing. Affected units include specific serial numbers.
QiagenMar 12, 2025 - Lower riskMedical device
Qiagen Sciences LLC recalls QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in
Qiagen recalls QIAcube Connect MDx instruments with heater shaker modules that may not heat below 40°C, causing delayed or erroneous DNA results. Affected units have serial numbers 30000-30506.
QiagenJun 3, 2024 - Lower riskMedical device
Qiagen Sciences LLC recalls EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic
Qiagen recalls EZ2 Connect MDx-IVD molecular diagnostic devices due to heater cable issues that can cause sample loss. Affected models include 9003230 and many other serial numbers listed. No remedy specified in recall notice.
QiagenMar 4, 2024 - Lower riskMedical device
Qiagen Sciences LLC recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Qiagen recalls specific SARS-CoV-2 test cartridges that may produce false negative results due to faulty manufacturing. Affected units include certain lot and serial numbers from the QIAstat-Dx Respiratory SARS-CoV-2 Panel test.
QiagenApr 28, 2023 - Lower riskMedical device
Qiagen Sciences LLC recalls FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
Qiagen recalls FGFR RGQ RT-PCR Kit (RUO) with risk of false positive results causing incorrect cancer treatment reports. Affected units have specific lot numbers and expiration dates.
QiagenJul 20, 2022 - Lower riskMedical device
Qiagen Sciences LLC recalls therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
Qiagen recalls KRAS RGQ PCR Kit (24) Model REF 870021 due to false positive/negative results for KRAS mutations, potentially invalidating test outcomes.
QiagenFeb 25, 2022 - Lower riskMedical device
Qiagen Sciences LLC recalls QIAcube Connect MDx, Model No. 9003070
Qiagen recalls QIAcube Connect MDx (Model 9003070) due to incorrect volume guidance during sample loading, which may cause false negative or positive test results. Affected units have specific serial numbers listed in the recall notice.
QiagenNov 21, 2021 - Lower riskMedical device
Qiagen Sciences LLC recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Qiagen recalls 16 faulty SARS-CoV-2 test cartridges (LOT 210209) that may cause false negative or positive results. Affected units have specific serial numbers.
QiagenNov 8, 2021 - Lower riskMedical device
Qiagen Sciences LLC recalls SARS-CoV-2 Antigen Test
Qiagen recalls SARS-CoV-2 Antigen Test kits with potential for false positives in some patient samples. Learn about affected lots and how to handle the product.
QiagenJan 15, 2021 - Lower riskMedical device
Qiagen Sciences LLC recalls therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be
Qiagen recalls PIK3:3CA RGQ PCR Kit (23) US IVD product due to potential false positive results for breast cancer mutation testing. Affected kits may misidentify patients for PIQRAY treatment.
QiagenDec 11, 2020 - Lower riskMedical device
Qiagen Sciences LLC recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative
Qiagen recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 due to increased false positives for Influenza A, risking incorrect treatment and delayed diagnosis. Affected units include specific lots.
QiagenJul 15, 2020 - Lower riskMedical device
Qiagen Sciences LLC recalls therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Qiagen recalls Therascreen EGFR RGQ PCR Kit (24) due to rare false mutation positive results from fluorescence artefacts. All lots affected. No remedy specified.
QiagenApr 8, 2020 - Lower riskMedical device
Qiagen Sciences LLC recalls AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10
Qiagen recalls AmniSure ROM Test kits with incorrect rinse time instructions. The correct rinse time is 1 minute, not 30 seconds. Affected kits include specific US and Canadian models.
QiagenFeb 21, 2020 - Lower riskMedical device
Qiagen Sciences LLC recalls QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time
Qiagen recalls software version 2.3.4 for Rotor Gene Q PCR analyzers that may report false negative results in certain tests, risking treatment suspension or non-initiation of medical treatment.
QiagenJan 28, 2020 - Lower riskMedical device
Qiagen Sciences LLC recalls QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed
Qiagen recalls software version 5.0.3 for QIAsymphony SP instruments due to potential incorrect patient reporting if 2D bar codes aren't verified before downstream applications. Affected units include specific serial numbers listed in the recall.
QiagenJul 2, 2019 - Lower riskMedical device
Qiagen Sciences LLC recalls Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS
Qiagen recalls Filter-Tips (1500 ul) used with QIAsymphony SP/AS instruments due to leaking tips in some lots. Affected lots: 0605020019 and 0605020020. Stop using if leaking.
QiagenJun 5, 2019 - Lower riskMedical device
Qiagen Sciences LLC recalls EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform
Qiagen recalls EZ1 Advanced XL model 9001492 due to potential heater malfunction from a power PCB issue, which may require repeating nucleic acid extractions and delaying results.
QiagenJul 23, 2018
Qiagen Sciences LLC recall questions
How many recalls has Qiagen Sciences LLC had?
20 recalls from Qiagen Sciences LLC are on record with U.S. safety agencies, from 2018–2025.
What is the most recent Qiagen Sciences LLC recall?
Qiagen Sciences LLC recalls Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version:, dated Mar 12, 2025. Every Qiagen Sciences LLC recall is listed on this page, newest first.
What should I do if I have a recalled Qiagen Sciences LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Qiagen Sciences LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.