Events

Recall of Quidel MicroVue Intact PTH EIA, Model 8044

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Diagnostic Hybrids, 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
    79595
  • Event Risk Class
    Class 3
  • Event Number
    Z-1520-2018
  • Event Initiated Date
    2016-10-26
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162740
  • 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
    Radioimmunoassay, parathyroid hormone - Product Code CEW
  • Reason
    There may be a loss of separation between calibrators a and b which may impact the assay calibration at the lower end of the assay.
  • Action
    Customers were notified via letter and email on 10/26/16. Customers were asked to complete and return the attached response form to the recalling firm. Customers were asked to review inventory, quarantine the products with the specified lot numbers, and, if further distributed, identify and notify any additional customers.

Device

Quidel MicroVue Intact PTH EIA, Model 8044
  • Model / Serial
    Lot 068259
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to the following countries: Singapore, Switzerland
  • Product Description
    Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
  • Manufacturer
    Diagnostic Hybrids, Inc.

Manufacturer

Diagnostic Hybrids, Inc.
  • Manufacturer Address
    Diagnostic Hybrids, Inc., 2005 E State St Ste 100, Athens OH 45701-2125
  • Manufacturer Parent Company (2017)
    Quidel Corporation
  • Source
    USFDA