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 -IVD intended for the detection and Recalled by Qiagen GmbH Due to If cartridges of the affected Serial numbers (SNs)...
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 -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223
Quantity: 368 kits
Why Was This Recalled?
If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported
Where Was This Sold?
This product was distributed to 17 states: AL, AR, CA, FL, GA, ID, KS, KY, MD, MN, NJ, NY, PA, SC, TX, VA, 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