Recall Z-2938-2020— Qiagen Sciences LLC
Class II · Terminated
Class II FDA medical device recall by Qiagen Sciences LLC, initiated 2020-07-15, terminated 2021-03-22. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Qiagen Sciences LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-15
- Terminated
- 2021-03-22
- Firm location
- Germantown, MD, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.