Qiagen Sciences LLC
Complete recall history across all FDA and CPSC categories — 21 total recalls
Qiagen Sciences LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (21)
FDA medical device enforcement actions by Qiagen Sciences LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 12, 2025 | Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Refe... | Identified faulty cartridges. If such a faulty cartridge is used for sample t... | Class II |
| Jun 3, 2024 | QIAcube Connect MDx - IVD Instrument designed to perform automated isolation ... | Heater shaker module does not perform heating if the temperature is set below... | Class II |
| Mar 4, 2024 | EZ2 Connect MDx-IVD Designed to perform automated isolation and purification ... | Insufficient welding leads to the heater cable becoming brittle and present ... | Class II |
| Apr 28, 2023 | QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PC... | Faulty cartridges in the lot could result in false test results. | Class II |
| Jul 20, 2022 | therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721 | Increased occurrence rate of false positive results, lead to a false positiv... | Class II |
| Jul 20, 2022 | therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 | Increased occurrence rate of false positive results, lead to a false positiv... | Class II |
| Jul 20, 2022 | FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010 | Increased occurrence rate of false positive results, lead to a false positiv... | Class II |
| Feb 25, 2022 | therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the... | False positive or false negative G12C (12CYS) mutation result for the KRAS Mu... | Class II |
| Feb 25, 2022 | therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD) | False positive or false negative G12C (12CYS) mutation result for the KRAS Mu... | Class II |
| Nov 21, 2021 | QIAcube Connect MDx, Model No. 9003070 | During the "Load tip racks and enzymes" step of the run set-up, the info scre... | Class II |
| Nov 8, 2021 | QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 69... | The firm identified sixteen (16) faulty cartridges in LOT 210209, which conta... | Class II |
| Jan 15, 2021 | SARS-CoV-2 Antigen Test | QIAGEN has become aware of the potential for false positive results to occur ... | Class II |
| Dec 11, 2020 | therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identif... | Kit may generate false Q546R mutation positive results caused by nonspecific ... | Class II |
| Jul 15, 2020 | QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - P... | There is an increased rate of potential false positive results for the Influe... | Class II |
| Apr 8, 2020 | therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121 | There is a risk for a false mutation positive result in rare cases resulting ... | Class II |
| Feb 21, 2020 | AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box)... | An image on the associated polybag contains an incorrect rinse time of 30 (th... | Class II |
| Jan 28, 2020 | QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed... | When using the Rotor-Gene Q with Software version 2.3.4 completing a LIMs exp... | Class II |
| Jul 2, 2019 | QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (T... | QIAsymphony software version 5.0.3 - Software issue incorreclty assigns the ... | Class II |
| Jun 5, 2019 | Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used ... | Kit lots contain a small percentage of damaged Filter-Tips that are leaking w... | Class I |
| Jul 23, 2018 | EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage... | An issue with the power branching printed circuit board (PCB) on the instrume... | Class II |
| Feb 2, 2016 | QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an i... | Potential for obtaining a false positive result due to the possibility ... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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