Qiagen recalls

Qiagen has 6 recalls on record with the FDA and USDA, the earliest in 2017 and the latest reported on 11 Oct 2023. 4 are still ongoing. The most frequent reason is lead & heavy metals.

Total recalls6since 2017

Last 12 months0reported

Class I00% of total

Ongoing4latest 11 Oct 2023

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 6 100%Class III 0 0%

Why qiagen is recalled

Lead & Heavy Metals350%
Other Reasons350%

Product types

By year

2023467%
2018117%
2017117%

Ongoing qiagen recalls

4 active

Reported	Class	Recall	Company	Reason	Where
11 Oct 2023Device	CLASS II	therascreen ¿KRAS RGQ PCR Kit -IVD qualitative PCR assay recalled	Qiagen	Lead & Heavy Metals	Nationwide
2 Aug 2023Device	CLASS II	QIAstat-Dx Respiratory Sars-CoV-2 Panel (V1 and V2, CE IVD recalled	Qiagen	Other	14 states
2 Aug 2023Device	CLASS II	QIAstat-Dx Respiratory Sars-CoV-2 Panel -US IVD qualitative recalled	Qiagen	Other	14 states
2 Aug 2023Device	CLASS II	QIAstat-Dx¿ Respiratory Sars-CoV-2 Panel -IVD intended recalled	Qiagen	Lead & Heavy Metals	17 states

All qiagen recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
11 Oct 2023Device	CLASS II	therascreen ¿KRAS RGQ PCR Kit -IVD qualitative PCR assay recalled	Qiagen	Lead & Heavy Metals	Nationwide
2 Aug 2023Device	CLASS II	QIAstat-Dx Respiratory Sars-CoV-2 Panel (V1 and V2, CE IVD recalled	Qiagen	Other	14 states
2 Aug 2023Device	CLASS II	QIAstat-Dx Respiratory Sars-CoV-2 Panel -US IVD qualitative recalled	Qiagen	Other	14 states
2 Aug 2023Device	CLASS II	QIAstat-Dx¿ Respiratory Sars-CoV-2 Panel -IVD intended recalled	Qiagen	Lead & Heavy Metals	17 states
8 Aug 2018Device	CLASS II	EZ1 DSP Virus Kit , IVD recalled by QIAGEN	QIAGEN	Lead & Heavy Metals	Nationwide
27 Dec 2017Device	CLASS II	QIAamp DSP Virus Kit recalled by Qiagen	Qiagen	Other	AR, DE, IN

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.