The Recall Desk

Manufacturer

OraSure Technologies, Inc.

10 recalls in our database name OraSure Technologies, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
10
Critical
0
Severe
0
Most recent
2021-03-17

Of the 10 recalls from OraSure Technologies, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–10 of 10

  • LowFDA (Devices)·Z-1183-2021·2021-03-17

    OraSure Methamphetamine Test Kit Recalled for Incorrect Reagent Lot Labeling

    OraSure Technologies is recalling 16 units of Methamphetamine Intercept Microplate kits due to a labeling error where the wrong lot number was printed on the box.

    Product
    Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3001-2020·2020-09-30

    OraSure CVS Advanced Wart Remover Kit Recalled for Improper Sealing

    OraSure Technologies is recalling CVS Advanced Wart Remover Kits because unit boxes were not properly sealed. The recall covers 23,400 units distributed in the US, Canada, and Brazil.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3003-2020·2020-09-30

    OraSure Pointts Skin Tag Removal System Recalled for Unsealed Boxes

    OraSure Technologies is recalling Pointts skin tag removal systems because unit boxes were not properly sealed. The recall affects 23,220 units distributed in the US, Canada, and Brazil.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3002-2020·2020-09-30

    OraSure Personelle OTC Skin Tag Remover Recalled for Improperly Sealed Boxes

    OraSure Technologies is recalling 3,000 units of Personelle OTC Skin Tag Remover because unit boxes were not properly sealed.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2876-2020·2020-09-02

    OraSure Benzodiazepine Micro-Plate Recall Due to Incorrect Lot Number Labeling

    OraSure Technologies is recalling 39 kits of the Interept Benzodiazepine Micro-Plate EIA due to incorrect lot numbers on the specification sheet and unit box.

    Product
    Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2877-2020·2020-09-02

    OraSure Benzodiazepine Micro-Plate Recalled for Incorrect Lot Number Labeling

    OraSure Technologies is recalling 13 kits of Interept Benzodiazepine Micro-Plates due to incorrect lot numbers on specification sheets and unit boxes.

    Product
    Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1419-2018·2018-04-25

    OraSure Cocaine Metabolite Test Kit Recalled for False Positive Results

    OraSure Technologies is recalling 10 units of Cocaine Metabolite MICRO-PLATE EIA kits because controls may cause false positive results.

    Product
    Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0722-2017·2016-12-14

    OraSure Barbiturate Micro-Plate EIA Recalled for Shipping Error

    OraSure Technologies is recalling four kits of Barbiturates Intercept Micro-Plate EIA because cocaine metabolite microplates were shipped instead.

    Product
    Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2403-2016·2016-08-24

    OraSure Recalls OraQuick Ebola Rapid Antigen Test Due to Stability Failures

    OraSure Technologies is recalling 3,075 units of the OraQuick Ebola Rapid Antigen Test because stability testing revealed intermittent false negative results.

    Product
    OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative detection of antigens for Ebola viruses.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1509-2016·2016-04-27

    OraSure Recalls OraQuick HCV Visual Reference Panel Due to Incorrect Insert

    OraSure Technologies is recalling 244 OraQuick HCV Visual Reference Panel kits because the package insert may be incorrect, potentially containing instructions for a different test.

    Product
    OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

OraSure Technologies

medical device company

Official website

Source: Wikidata (Q7099189), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.