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 under FDA EUA 200075) Recalled by Qiagen Sciences LLC Due to The firm identified sixteen (16) faulty cartridges in...
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 Sciences LLC directly.
Affected Products
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Quantity: 376 kits
Why Was This Recalled?
The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.
Where Was This Sold?
This product was distributed to 9 states: AL, KY, ME, MD, NJ, OK, PA, TX, DC
About Qiagen Sciences LLC
Qiagen Sciences LLC has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report