Home › Device types › QLT
Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices
FDA product code QLT · Class N · Unknown
3
Registered devices
1,693
Adverse events
11
Recalls
0
510(k) clearances
Devices with this code
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-05 | Luminex Molecular Diagnostics Inc | Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, |
| 2023-05-19 | Qiagen GmbH | Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated |
| 2023-05-19 | Qiagen GmbH | Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated |
| 2023-04-28 | Qiagen Sciences LLC | Faulty cartridges in the lot could result in false test results. |
| 2022-12-21 | Roche Molecular Systems, Inc. | The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result |
| 2022-12-21 | Roche Molecular Systems, Inc. | The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result |
| 2022-12-21 | Roche Molecular Systems, Inc. | The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result |
| 2022-05-13 | NeuMoDx Molecular Inc | There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false nega |
| 2021-11-08 | Qiagen Sciences LLC | The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge |
| 2021-08-04 | Roche Molecular Systems, Inc. | Customers have reported an increased number of false positive SARS-CoV-2 results. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.