OraSure Technologies recalls

OraSure Technologies has 10 recalls on record with the FDA and USDA, the earliest in 2016 and the latest reported on 17 Mar 2021. The most frequent reason is packaging defects.

Total recalls10since 2016

Last 12 months0reported

Class I110% of total

Ongoing0latest 17 Mar 2021

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 10%Class II 0 0%Class III 9 90%

Why orasure technologies is recalled

Product types

By year

2021110%
2020550%
2018110%
2016330%

All orasure technologies recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
17 Mar 2021Device	CLASS III	Methamphetamine Intercept Microplate kit EIA recalled	OraSure Technologies	Other	Nationwide
30 Sep 2020Device	CLASS III	CVS Advanced Wart Remover Kit recalled by OraSure Technologies	OraSure Technologies	Packaging Defects	Nationwide
30 Sep 2020Device	CLASS III	Personelle OTC Skin Tag Remover, Canada Catalog Number recalled	OraSure Technologies	Packaging Defects	Nationwide
30 Sep 2020Device	CLASS III	Pointts sistema de ellmlnact!;o de verrugas recalled	OraSure Technologies	Packaging Defects	Nationwide
2 Sep 2020Device	CLASS III	Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate recalled	OraSure Technologies	Potency & Assay	Nationwide
2 Sep 2020Device	CLASS III	Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate recalled	OraSure Technologies	Potency & Assay	Nationwide
25 Apr 2018Device	CLASS III	Cocaine Metabolite Micro-plate EIA recalled by OraSure Technologies	OraSure Technologies	Other	KS
14 Dec 2016Device	CLASS III	Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay recalled	OraSure Technologies	Potency & Assay	KS, VA
24 Aug 2016Device	CLASS I	OraQuick Ebola Rapid Antigen Test, Product recalled	OraSure Technologies	Potency & Assay	GA
27 Apr 2016Device	CLASS III	OraQuick HCV Visual Reference Panel Intended to assist new recalled	OraSure Technologies	Packaging Defects	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.