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OraSure Technologies Recalls
10 recalls on record · April 27, 2016 to March 17, 2021 · Medical Devices
Recalls by year
16
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21
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 17, 2021Medical DevicesFDA
OraSure Technologies, Inc. recalls Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C
Hazard: Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate Reagent (TMB) lot 6679623, should not affect performance.
September 30, 2020Medical DevicesFDA
OraSure Technologies, Inc. recalls Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-
Hazard: Unit boxes not properly sealed
September 30, 2020Medical DevicesFDA
OraSure Technologies, Inc. recalls Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cr
Hazard: Unit boxes not properly sealed
September 30, 2020Medical DevicesFDA
OraSure Technologies, Inc. recalls CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical
Hazard: Unit boxes not properly sealed
September 2, 2020Medical DevicesFDA
OraSure Technologies, Inc. recalls Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD
Hazard: Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
September 2, 2020Medical DevicesFDA
OraSure Technologies, Inc. recalls Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Im
Hazard: Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
April 25, 2018Medical DevicesFDA
OraSure Technologies, Inc. recalls Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
Hazard: The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
December 14, 2016Medical DevicesFDA
OraSure Technologies, Inc. recalls Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical labo
Hazard: Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
August 24, 2016Medical DevicesFDA
OraSure Technologies, Inc. recalls OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebo
Hazard: Failed stability testing at 8 months. This lot produced intermittent false negative results for the positive kit control with devices stored at 30C conditions.
April 27, 2016Medical DevicesFDA
OraSure Technologies, Inc. recalls OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens wit
Hazard: OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a complaint received from one of their customers. The customer reported they received the Ora Quick Ebola Visual Reference Panel instead of an OraQuick HCV Visual Reference Panel.