Stock: QDEL. Includes companies and brands it has bought. Official US government data, updated September 2026.
510(k) clearances
275
De Novo: 4
PMA approvals
9
211 supplements
Recalled products
373
2 class I
Adverse event reports
29K
7 deaths reported
QuidelOrtho has 373 recalled medical device products in 212 recall actions in the records, 2 of them class I (the most serious kind). The newest recall started on Apr 6, 2026. In 2025 it had 14 recalled products.
275 510(k) clearances, 4 De Novo grants and 9 original PMA approvals for high-risk devices, plus 211 PMA supplements (changes to approved devices). The newest decision was on Sep 4, 2026.
29,499 reports in total: 7 deaths, 193 injuries and 29,075 malfunctions were reported. 1,016 reports were received in 2025. A report alone does not show that the device caused the problem.
Last 15 years
| Year | 510(k) clearance | De Novo grant | PMA approval | PMA supplement |
|---|---|---|---|---|
| 2026 | 3 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 |
| 2024 | 3 | 0 | 0 | 0 |
| 2023 |
By product code, all years
All device makers and procedures · QDEL stock page
Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to QDEL with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.
| 7 |
| 3 |
| 0 |
| 3 |
| 2022 | 3 | 0 | 0 | 0 |
| 2021 | 3 | 0 | 0 | 0 |
| 2020 | 2 | 0 | 0 | 2 |
| 2019 | 6 | 0 | 0 | 7 |
| 2018 | 6 | 0 | 0 | 25 |
| 2017 | 10 | 0 | 0 | 7 |
| 2016 | 8 | 0 | 0 | 3 |
| 2015 | 4 | 0 | 0 | 18 |
| 2014 | 6 | 1 | 0 | 2 |
| 2013 | 14 | 0 | 0 | 5 |
| 2012 | 4 | 0 | 0 | 22 |
| 2011 | 3 | 0 | 0 | 6 |
Recalled products, class I, and reports received
| Year | Recalls | Class I | Reports | Deaths |
|---|---|---|---|---|
| 2026 | 1 | 0 | 514 | - |
| 2025 | 14 | 0 | 1,016 | - |
| 2024 | 30 | 0 | 1,175 | - |
| 2023 | 24 | 1 | 2,242 | 2 |
| 2022 | 8 | 0 | 10,698 | - |
| 2021 | 12 | 1 | 802 | - |
| 2020 | 29 | 0 | 694 | 1 |
| 2019 | 34 | 0 | 566 | - |
| 2018 | 23 | 0 | 714 | 1 |
| 2017 | 16 | 0 | 613 | - |
| 2016 | 23 | 0 | 723 | - |
| 2015 | 19 | 0 | 768 | 1 |
| 2014 | 30 | 0 | 700 | - |
| 2013 | 59 | 0 | 948 | - |
| 2012 | 15 | 0 | 930 | 1 |