SD Biosensor, Inc. recalls
Every recall we track for SD Biosensor, Inc. — 2 in all, from 2022–2023 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
2 recalls since 2017.
All FDA recall records for SD Biosensor, Inc. 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 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 1 | 1 |
| 2023 | 0 | 0 | 1 | 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 SD Biosensor, Inc. 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 SD Biosensor, Inc. recalls
2 shown- Lower riskMedical device
SD Biosensor, Inc. recalls Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207
SD Biosensor recalls Pilot COVID-19 At-Home Test kits with bacterial contamination in liquid buffer. Affected lots may have a slight odor when buffer is near nose. Consumers should stop using these specific lots.
SD BiosensorMar 31, 2023 - UnratedMedical device
SD Biosensor, Inc. recalls STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the
SD Biosensor recalls STANDARD Q COVID-19 Ag Home Test kits imported illegally into the U.S. that aren't approved for distribution. These tests may not be safe or effective.
SD BiosensorJan 31, 2022
SD Biosensor, Inc. recall questions
How many recalls has SD Biosensor, Inc. had?
2 recalls from SD Biosensor, Inc. are on record with U.S. safety agencies, from 2022–2023.
What is the most recent SD Biosensor, Inc. recall?
SD Biosensor, Inc. recalls Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207, dated Mar 31, 2023. Every SD Biosensor, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled SD Biosensor, Inc. 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 SD Biosensor, Inc. 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.