PlainRecalls

Qiagen Sciences LLC

Compiled from official public sources by the publisher.

21 recalls on record · Latest: Apr 9, 2025

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Agency notice ledger

Federal filing book Qiagen Sciences LLC MID-BOOK · SINGLE-AGENCY

#784 of 14,151 · 21 notices · 0.020% archive

  • BOOK 21 notices
  • RANK #784 of 14,151
  • SHARE 0.020% archive
  • AGENCY FDA Devices (21)
  • CAT medical devices
  • CATS 1 category
  • LATEST Apr 9, 2025
  • PHOTO A&h Focal Inc.

Nearest notice-volume peer: A&h Focal Inc. (0 notice gap)

Qiagen Sciences LLC accounts for about 0.020% of the 104,423-notice archive on 21 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Qiagen Sciences LLC sits among 14,151 recalling firms

Qiagen Sciences LLC ranks 784th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Qiagen Sciences LLC vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

21 784th of 14151 higher than 13,362 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Qiagen Sciences LLC in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Qiagen Sciences LLC holds about 0.020% of archive notices alongside 21 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
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 molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1
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 applications. Model Number: 9003230
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 PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121
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 of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider.
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 Distribution; 25 tests/box)
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 purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids. It is intended to be used only in combination with QIAsymphony kits indicated for use with the QIAsymphony SP for the applications described in the kit handbooks. The QIAsymphony SP is inten
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) REF: 997024 Used in sample preparation
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 purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1 Advanced XL instrument for the applications described in the kit handbooks. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of
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)

Qiagen Sciences LLC holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (21 here).

A&h Focal Inc. 21 Able Groupe Inc 21 Alvogen, Inc 21 Aroa Biosurgery, LTD. 21 Aston Martin 21

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Aroa Biosurgery, LTD. 21 Corin Ltd 21 Covidien 21 Custom Medical Specialties, Inc. 21

Frequently Asked Questions

How many federal recall notices name Qiagen Sciences LLC? ▼
PlainRecalls indexes 21 distinct federal recall events naming Qiagen Sciences LLC, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Qiagen Sciences LLC sit among other recalling firms? ▼
Qiagen Sciences LLC ranks #784 of 14,151 by distinct recall-event count among 14,151 firms in this archive (94th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Qiagen Sciences LLC's notices? ▼
FDA Devices accounts for 21 of this firm's 21 indexed notices.
What product category dominates Qiagen Sciences LLC's filing book? ▼
Filings for Qiagen Sciences LLC span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Qiagen Sciences LLC: 21 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Qiagen Sciences LLC; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026