Events

Recall of Device Recall MicroVue BAP EIA, Model 8012

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
    79621
  • Event Risk Class
    Class 2
  • Event Number
    Z-1797-2018
  • Event Initiated Date
    2016-07-14
  • 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=162843
  • 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
    Electrophoretic separation, alkaline phosphatase isoenzymes - Product Code CIN
  • Reason
    There is a possibility of low volume and/or leaking standard bottles.
  • Action
    Customers were contacted via telephone and a letter dated 7/14/16. The letter instructed customers to review their inventory for the specified lot number, check for any low-volume or leaking standards, and contact the recalling firm if necessary.

Device

Device Recall MicroVue BAP EIA, Model 8012
  • Model / Serial
    Lot 067850
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were distributed to the following US states: CA, CT, GA, IL, KY, MA, MD, MO, PA, TX, WA, and WI. The products were distributed to the following foreign countries: Australia, Brazil, Canada, China, Costa Rica, India, Japan, Mexico, The Philippines, Russia, South Korea, South Africa, Switzerland, and Uruguay.
  • Product Description
    MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity 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