Qiagen SARS-CoV-2 Test Panel Recalled for Influenza A False Positives
Qiagen is recalling 1,474 QIAstat-Dx Respiratory SARS-CoV-2 Panel kits due to an increased rate of false positive results for Influenza A, which may lead to inappropriate antiviral use or delayed diagnosis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm through inappropriate medical treatment (antiviral use) and delayed diagnosis, but the source text does not report any specific injuries, hospitalizations, or fatalities, fitting the criteria for a High severity score.
Plain-English summary
Qiagen Sciences LLC is recalling 1,474 units of the QIAstat-Dx Respiratory SARS-CoV-2 Panel (REF 691223). This in vitro diagnostic (IVD) test is 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 collected from patients suspected of COVID-19.
The recall is being issued because there is an increased rate of potential false positive results for the Influenza A (no subtype) target. These false positives may lead to inappropriate antiviral use, erroneous or delayed differential diagnosis, and the missing of an alternative diagnosis.
The affected lots are 166020729, 166022794, 166023368, 166023399, 166023400, 166024163, 166024165, 166024166, 166025078, 166025888, 166025889, 166028721, 166028722, 166029506, and 166029508. The product was distributed nationwide in the United States, 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, and WA. Healthcare providers and laboratories should stop using the affected lots and contact the manufacturer for instructions on return or disposal.
The recalled product
- 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 (
- Manufacturer
- Qiagen Sciences LLC
- Affected units
- 1,474
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- lots 166020729
- 166022794
- 166023368
- 166023399
- 166023400
- 166024163
- 166024165
- 166024166
- 166025078
- 166025888
- 166025889
- 166028721
- 166028722
- 166029506
- 166029508
Distribution
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