Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for Recalled by Qiagen GmbH Due to Identified a decreased performance reliability rate, Run abortions...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Qiagen GmbH directly.
Affected Products
QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing nasopharyngeal swab (NPS) samples from patients suspected of respiratory infection for the presence of viral or bacterial nucleic acids REF 691223
Quantity: 386 kits
Why Was This Recalled?
Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated
Where Was This Sold?
This product was distributed to 14 states: AL, CA, DE, FL, GA, ID, IN, ME, NY, NC, OR, TN, TX, DC
About Qiagen GmbH
Qiagen GmbH has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report