Bethlehem, PA, United States
OraSure Technologies, Inc. recalls
4 recalls recorded since 2018, most recently on 5 February 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)0
Terminated Class III Medical devices
- Recall started
- 5 February 2021
- Terminated
- 30 March 2023
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of KS, NJ, OH, VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1183-2021
- Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
Terminated Class III Medical devices
- Recall started
- 15 July 2020
- Terminated
- 14 March 2022
- Reason
- Unit boxes not properly sealed
- Distribution
- Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3003-2020, Z-3002-2020, Z-3001-2020
- Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
- Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
- CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts.
Terminated Class III Medical devices
- Recall started
- 13 July 2020
- Terminated
- 8 June 2021
- Reason
- Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of DC, FL, PA, MD, NM, NY, NV, PA and the country of France.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2877-2020, Z-2876-2020
- Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
- Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
Terminated Class III Medical devices
- Recall started
- 20 December 2017
- Terminated
- 2 April 2020
- Reason
- The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
- Distribution
- Distributed to 2 consignees in KS.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1419-2018
- Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.