Qiagen Sciences recalls

Qiagen Sciences has 23 recalls on record with the FDA and USDA, the earliest in 2016 and the latest reported on 9 Apr 2025. 11 are still ongoing.

Total recalls23since 2016

Last 12 months0reported

Class I29% of total

Ongoing11latest 9 Apr 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 1Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 9%Class II 21 91%Class III 0 0%

Why qiagen sciences is recalled

Product types

By year

202514%
202429%
202314%
2022730%
202129%
2020417%
2019313%
201829%
201614%

Ongoing qiagen sciences recalls

11 active

Reported	Class	Recall	Company	Reason	Where
9 Apr 2025Device	CLASS II	QIAstat-Dx Respiratory Panel Plus Reference Number recalled	Qiagen Sciences	Device Malfunction	12 states
24 Jul 2024Device	CLASS II	QIAcube Connect MDx - IVD Instrument designed to perform recalled	Qiagen Sciences	Potency & Assay	Nationwide
17 Apr 2024Device	CLASS II	EZ2 Connect MDx-IVD Designed to perform automated isolation recalled	Qiagen Sciences	Temperature Abuse	Nationwide
14 Jun 2023Device	CLASS II	QIAstat-Dx Respiratory Sars-CoV-2 Panel multiplexed nucleic recalled	Qiagen Sciences	Other	Nationwide
21 Sep 2022Device	CLASS II	QIAcube Connect MDx recalled by Qiagen Sciences	Qiagen Sciences	Lead & Heavy Metals	Nationwide
7 Sep 2022Device	CLASS II	therascreen Fgfr Rgq Rt-pcr kit (US Ivd) recalled by Qiagen Sciences	Qiagen Sciences	Lead & Heavy Metals	4 states

All qiagen sciences recalls, newest first

23 total

Reported	Class	Recall	Company	Reason	Where
9 Apr 2025Device	CLASS II	QIAstat-Dx Respiratory Panel Plus Reference Number recalled	Qiagen Sciences	Device Malfunction	12 states
24 Jul 2024Device	CLASS II	QIAcube Connect MDx - IVD Instrument designed to perform recalled	Qiagen Sciences	Potency & Assay	Nationwide
17 Apr 2024Device	CLASS II	EZ2 Connect MDx-IVD Designed to perform automated isolation recalled	Qiagen Sciences	Temperature Abuse	Nationwide
14 Jun 2023Device	CLASS II	QIAstat-Dx Respiratory Sars-CoV-2 Panel multiplexed nucleic recalled	Qiagen Sciences	Other	Nationwide
21 Sep 2022Device	CLASS II	QIAcube Connect MDx recalled by Qiagen Sciences	Qiagen Sciences	Lead & Heavy Metals	Nationwide
7 Sep 2022Device	CLASS II	therascreen Fgfr Rgq Rt-pcr kit (US Ivd) recalled by Qiagen Sciences	Qiagen Sciences	Lead & Heavy Metals	4 states
7 Sep 2022Device	CLASS II	therascreen Fgfr Rgq Rt-pcr Kit (CE Ivd, not recalled by Qiagen Sciences	Qiagen Sciences	Lead & Heavy Metals	4 states
7 Sep 2022Device	CLASS II	Fgfr Rgq Rt-pcr Kit (Ruo, not Ivd) recalled by Qiagen Sciences	Qiagen Sciences	Lead & Heavy Metals	4 states
27 Apr 2022Device	CLASS II	therascreen KRAS RGQ PCR Kit recalled by Qiagen Sciences	Qiagen Sciences	Other	14 states
27 Apr 2022Device	CLASS II	therascreen KRAS RGQ PCR Kit recalled by Qiagen Sciences	Qiagen Sciences	Other	14 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.