medical Class II Updated 2020-09-16

Qiagen Sciences LLC recalls QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD u

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: lots 166020729, 166022794, 166023368, 166023399, 166023400, 166024163, 166024165, 166024166, 166025078, 166025888, 166025889, 166028721, 166028722, 166029506, 166029508
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →