Events

Recall of Device Recall ORASURE Barbiturates Intercept MicroPlate EIA

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by OraSure Technologies, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75681
  • Event Risk Class
    Class 3
  • Event Number
    Z-0722-2017
  • Event Initiated Date
    2016-11-10
  • Event Date Posted
    2016-12-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151041
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Enzyme immunoassay, barbiturate - Product Code DIS
  • Reason
    Shipping error. cocaine metabolite microplate distributed instead of barbiturate microplate due to incorrect selection of microplate during manufacturing.
  • Action
    Due to the small number of customers that were affected by the recall, OraSure notified customers on November 10, 2016, via telephone with a follow-up email. Customers were asked to quarantine the units on hand and they will schedule a pickup by Fed EX to retrieve the affected units. For further questions, please call (610) 882-1820, ext. 1657

Device

Device Recall ORASURE Barbiturates Intercept MicroPlate EIA
  • Model / Serial
    Lot # 6654085
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to KS, and VA
  • Product Description
    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.
  • Manufacturer
    OraSure Technologies, Inc.

Manufacturer

OraSure Technologies, Inc.
  • Manufacturer Address
    OraSure Technologies, Inc., 1745 Eaton Ave, Bethlehem PA 18018-1769
  • Manufacturer Parent Company (2017)
    OraSure Technologies, Inc.
  • Source
    USFDA