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Qiagen Sciences LLC recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative
Recalled September 16, 2020 · FDA recall Z-2938-2020 · Qiagen Sciences
Hazard
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. · FDA Class II
Units
1474 kits
Sold at
US Nationwide distribution including in the states of AK, AL, CA, DC, DE, FL, GA, IL, IN, KY, MA, MD, MN, NC, NJ, NY, OH, OR, PA, TX, WA.
Description
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.
Product
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended 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.
Manufacturer(s)
Qiagen Sciences LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →