Qiagen Sciences LLC
16 recalls on record · Latest: Apr 9, 2025
Qiagen Sciences LLC Recall Insight
Qiagen Sciences LLC appears on 16 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.019% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Apr 9, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.
On this page of 16 entries, severity tagging shows 1 critical, 15 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 16 of 16 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (16). The date window on this page runs from Nov 14, 2018 to Apr 9, 2025.
Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecul…
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applic…
QIAcube Connect MDx, Model No. 9003070
FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
SARS-CoV-2 Antigen Test
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRA…
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation…
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purificati…
Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) …
EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and pu…
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Other firms with recall activity tracked in the PlainRecalls index.
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