PlainRecalls

Qiagen Sciences LLC

Compiled from official public sources by the editorial team.

21 recalls on record · Latest: Apr 9, 2025

Qiagen Sciences LLC Recall Insight

Qiagen Sciences LLC appears on 21 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.021% 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 21 entries, severity tagging shows 1 critical, 20 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 21 of 21 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 (21). The date window on this page runs from Mar 30, 2016 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.

FDA Devices Moderate Apr 9, 2025

Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a

FDA Devices Moderate Jul 24, 2024

QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecul…

FDA Devices Moderate Apr 17, 2024

EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applic…

FDA Devices Moderate Jun 14, 2023

QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223

FDA Devices Moderate Sep 21, 2022

QIAcube Connect MDx, Model No. 9003070

FDA Devices Moderate Sep 7, 2022

FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010

FDA Devices Moderate Sep 7, 2022

therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711

FDA Devices Moderate Sep 7, 2022

therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721

FDA Devices Moderate Apr 27, 2022

therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)

FDA Devices Moderate Apr 27, 2022

therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)

FDA Devices Moderate Jan 12, 2022

QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

FDA Devices Moderate Feb 10, 2021

SARS-CoV-2 Antigen Test

FDA Devices Moderate Feb 3, 2021

therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRA…

FDA Devices Moderate Sep 16, 2020

QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation…

FDA Devices Moderate Jun 17, 2020

therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121

FDA Devices Moderate Apr 8, 2020

AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian D…

FDA Devices Moderate Mar 18, 2020

QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.

FDA Devices Moderate Aug 28, 2019

QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purificati…

FDA Devices Critical Aug 7, 2019

Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) …

FDA Devices Moderate Nov 14, 2018

EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and pu…

FDA Devices Moderate Mar 30, 2016

QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.