OraSure Technologies, Inc.

Complete recall history across all FDA and CPSC categories — 10 total recalls

OraSure Technologies, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (10)

FDA medical device enforcement actions by OraSure Technologies, Inc.

Date Product Reason Class
Feb 5, 2021 Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination ... Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The orig... Class III
Jul 15, 2020 CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: ind... Unit boxes not properly sealed Class III
Jul 15, 2020 Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product... Unit boxes not properly sealed Class III
Jul 15, 2020 Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 100... Unit boxes not properly sealed Class III
Jul 13, 2020 Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate ... Incorrect lot number for Standard Oral Fluid Negative Calibrator on specifica... Class III
Jul 13, 2020 Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate... Incorrect lot number for Standard Oral Fluid Negative Calibrator on specifica... Class III
Dec 20, 2017 Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (01006083370... The controls and calibrators contained within the cocaine test kit may cause ... Class III
Nov 10, 2016 Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) P... Shipping error. Cocaine metabolite Microplate distributed instead of Barbitur... Class III
Jul 20, 2016 OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for th... Failed stability testing at 8 months. This lot produced intermittent false n... Class I
Jan 15, 2016 OraQuick HCV Visual Reference Panel Intended to assist new operation in b... OraSure Technologies, Inc. discovered the package insert included with the Or... Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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