Qiagen recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 due to increased false positives for Influenza A, risking incorrect treatment and delayed diagnosis. Affected units include specific lots.
There is an increased rate of potential false positive results for the Influenza A (no subtype) target, which may lead to 1) inappropriate antiviral use, 2) erroneous or delayed differential diagnosis and missing of an alternative diagnosis.
Qiagen is recalling its QIAstat-Dx Respiratory SARS-CoV-2 Panel (REF 691223) because it can produce false positive results for Influenza A. This may lead to unnecessary antiviral use or missed diagnoses of other conditions. The recall affects specific production lots sold under FDA EUA.
The panel may show a positive result for Influenza A when it's not actually present. This can cause doctors to give unnecessary antiviral treatments or delay proper diagnosis of other conditions, potentially missing critical health issues.
Healthcare providers using the QIAstat-Dx Respiratory SARS-CoV-2 Panel for COVID-19 testing are likely affected. Those testing patients with respiratory symptoms are at higher risk of incorrect results.
Check the product lot number on the QIAstat-Dx Respiratory SARS-CoV-2 Panel. Affected lots include 166020729, 166022794, 166023368, 166023399, 166023400, 166024163, 166024165, 166024166, 166025078, 166025888, 166025889, 166028721, 166028722, 166029506, and 166029508.
Look for the lot number on the QIAstat-Dx Respiratory SARS-CoV-2 Panel to see if it matches the affected lots listed.
The panel has an increased rate of false positive results for Influenza A, which could lead to inappropriate antiviral use or delayed diagnosis of other conditions.
The recall record does not specify a remedy for affected units. Check the lot number and contact Qiagen for further instructions.
The panel is intended for use in healthcare settings but may produce false positives for Influenza A, which could affect test accuracy.
We’ve drafted a message you can send Qiagen to request your refund or repair — edit it as you like.
Subject: Recall Z-2938-2020 — Qiagen Qiagen Hello, I own a Qiagen that is covered by recall Z-2938-2020 from Qiagen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
