OraSure Technologies, Inc. recalls
Every recall we track for OraSure Technologies, Inc. — 7 in all, from 2017–2021 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from OraSure Technologies, Inc. peaked in 2020 (5); 7 since 2017.
All FDA recall records for OraSure Technologies, 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 | 1 | 0 | 1 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 5 | 0 | 5 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for OraSure Technologies, Inc. recalls
What to do if you have a recalled OraSure Technologies, 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 OraSure Technologies, Inc. recalls
4 shown- Lower riskMedical device
OraSure Technologies, Inc. recalls Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN
OraSure recalls Methamphetamine Intercept Microplate kits with incorrect reagent lot numbers. This may affect test accuracy but does not cause injury. Consumers should check their kit's lot number and contact OraSure for details.
OraSureFeb 5, 2021 - Lower riskMedical device
OraSure Technologies, Inc. recalls Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for
OraSure recalls Brazil-cataloged Pointts skin tag cryosurgical system (lot 9214, 9256) due to unsealed unit boxes. Consumers should check for unsealed packaging before use.
OraSureJul 15, 2020 - Lower riskMedical device
OraSure Technologies, Inc. recalls Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD
OraSure recalls certain Benzodiazepine test kits due to incorrect lot numbers on calibrators and unit boxes. This may lead to inaccurate results. Check your kit's lot number and contact OraSure for details.
OraSureJul 13, 2020 - Lower riskMedical device
OraSure Technologies, Inc. recalls Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
OraSure Technologies recalls cocaine metabolite test kits that may cause false positive results with negative controls. Affected units include specific catalog numbers and expiration dates.
OraSureDec 20, 2017
OraSure Technologies, Inc. recall questions
How many recalls has OraSure Technologies, Inc. had?
7 recalls from OraSure Technologies, Inc. are on record with U.S. safety agencies, from 2017–2021.
What is the most recent OraSure Technologies, Inc. recall?
OraSure Technologies, Inc. recalls Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN, dated Feb 5, 2021. Every OraSure Technologies, Inc. recall is listed on this page, newest first.
Why are OraSure Technologies, Inc. products recalled?
The most common reasons on record: Unit boxes not properly sealed (3).
What should I do if I have a recalled OraSure Technologies, 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 OraSure Technologies, 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.