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.

Recall Insight

This FDA Devices action (record #Z-2938-2020) was formally reported on September 16, 2020, with the manufacturer initiating the action on July 15, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Qiagen Sciences LLC is listed as the recalling firm, operating out of Germantown, MD. Federal records list the affected scope as 1474 kits.

The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.