Qiagen Sciences LLC: Medical Device Recall in 2020 - (Recall #: Z-2938-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 15, 2020

Date Posted: September 16, 2020

Recall Number: Z-2938-2020

Event ID: 86149

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1474 kits

Code Information:

lots 166020729, 166022794, 166023368, 166023399, 166023400, 166024163, 166024165, 166024166, 166025078, 166025888, 166025889, 166028721, 166028722, 166029506, 166029508

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated