Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
FDA product code QLT · Not classified · Microbiology
Multi-analyte nucleic acid-based in vitro diagnostic devices for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that causes COVID-19, and common respiratory microorganisms in human respiratory and/or acceptable clinical specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Results should not be used as the sole basis for diagnosis, treatment or other patient management decisions and must be combined with clinical observations, patient history, and/or epidemiological information.
0510(k) clearances
0PMA approvals
11recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0043-2025 Class II | NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of… | Luminex Molecular Diagnostics Inc | 09/05/2024Open, Classified |
| Z-2246-2023 Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel (V1 and V2, CE IVD, not US IVD, not sold in the…Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since… | Qiagen GmbH | 05/19/2023Open, Classified |
| Z-2245-2023 Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test intended for analyzing…Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since… | Qiagen GmbH | 05/19/2023Open, Classified |
| Z-1683-2023 Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test…Faulty cartridges in the lot could result in false test results. | Qiagen Sciences LLC | 04/28/2023Open, Classified |
| Z-1106-2023 Class II | cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on…The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A… | Roche Molecular Systems, Inc. | 12/21/2022Open, Classified |
| Z-1105-2023 Class II | cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas…The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A… | Roche Molecular Systems, Inc. | 12/21/2022Open, Classified |
| Z-1104-2023 Class II | cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800…The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A… | Roche Molecular Systems, Inc. | 12/21/2022Open, Classified |
| Z-1251-2022 Class II | NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV… | NeuMoDx Molecular Inc | 05/13/2022Open, Classified |
| Z-0455-2022 Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes… | Qiagen Sciences LLC | 11/08/2021Terminated |
| Z-2498-2021 Class II | cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number…Customers have reported an increased number of false positive SARS-CoV-2 results. | Roche Molecular Systems, Inc. | 08/04/2021Terminated |
| Z-2938-2020 Class II | QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product…There is an increased rate of potential false positive results for the Influenza A (no subtype) target… | Qiagen Sciences LLC | 07/15/2020Terminated |