LumiraDx recalls
Every recall we track for LumiraDx — 6 in all, from 2021–2023 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from LumiraDx peaked in 2022 (3); 6 since 2017. 17% rated “stop using now”.
All FDA recall records for LumiraDx since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 1 | 0 | 2 |
| 2022 | 0 | 0 | 2 | 1 | 3 |
| 2023 | 0 | 1 | 0 | 0 | 1 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled LumiraDx product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All LumiraDx recalls
5 shown- Use cautionMedical device
LumiraDx recalls SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area.
LumiraDx recalls 25-unit packs of SteriPack sterile swabs that may break in nasal cavities, causing injury or requiring medical removal. Recalled lots expired by Oct 2023.
LumiraDxApr 25, 2023 - Lower riskMedical device
LumiraDx recalls LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2
LumiraDx recalls SARS-CoV-2 Antigen Liquid Quality Control Kits with incorrect vial lot numbers that may prevent proper testing. Affected kits could show error messages and fail to function correctly.
LumiraDxSep 23, 2022 - Lower riskMedical device
LumiraDx recalls LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
LumiraDx recalls SARS-CoV-2 Antibody tests with a quality control modification made outside approved EUA. Affected units have specific lot numbers and catalog codes.
LumiraDxJun 24, 2022 - Stop using nowMedical device
LumiraDx recalls Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid
LumiraDx recalls coronavirus antigen test systems that gave false positives due to failed QC testing. Stop using these products immediately to avoid inaccurate results.
LumiraDxFeb 3, 2021 - Lower riskMedical device
LumiraDx recalls LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2
LumiraDx recalls specific lots of SARS-CoV-2 antigen test strips due to potential false positives, which could lead to unnecessary treatment or quarantine. Affected lots include 5000269, 5000280, 5000306, 5000323, 6000142, and 6000100.
LumiraDxJan 11, 2021
LumiraDx recall questions
How many recalls has LumiraDx had?
6 recalls from LumiraDx are on record with U.S. safety agencies, from 2021–2023.
What is the most recent LumiraDx recall?
LumiraDx recalls SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area., dated Apr 25, 2023. Every LumiraDx recall is listed on this page, newest first.
What should I do if I have a recalled LumiraDx product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new LumiraDx recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.