Recall Z-2938-2020 ยท QLT Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
Qiagen Sciences LLC
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.
| Date | Jul 15, 2020 |
| Status | Terminated |
| 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. |
| Root cause | Material/Component Contamination |
| Action | On July 15, 2020, the firm distributed Urgent Medical Device Correction letters to affected customers to inform them of the increased rate of potential false positive results for the Influenza A (no subtype) target. Customers were instructed to do the following: l -Please review and reassess all Influenza A (no subtype) positive samples tested with the affected lots. -Please note that as per Instructions for Use if only an Influenza A signal is present and no additional signal for any of the subtypes is generated, it can be due to either low concentration or, in very rare cases, a new varian |
| Quantity | 1474 kits |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.