Reported Sep 16, 2020 · Terminated
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative…
Qiagen Sciences LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qiagen Sciences LLC · 19300 Germantown Rd · Germantown, MD · 20874-1415
Is this the product you have?
- QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US
- IVD under FDA EUA) - Product Usageintended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral and bacterial organisms, including the SARS-CoV-2 virus, in nasopharyngeal swabs (NPS) eluted in universal transport media collected from patients suspected of COVID-19 by their healthcare provider
- Lot codes and dates
lots 166020729166022794166023368166023399166023400166024163166024165166024166166025078166025888166025889166028721166028722166029506166029508
- Amount recalled
- 1474 kits
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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