Events

Recall of Device Recall MicroVue SC5b9 Plus EIA (RUO)

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
    79642
  • Event Risk Class
    Class 3
  • Event Number
    Z-1498-2018
  • Event Initiated Date
    2015-11-03
  • 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=162885
  • 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
    Research use only/immunology devices - Product Code OTR
  • Reason
    A component of the kit was found to contain bacterial contamination.
  • Action
    Customers were notified via letter dated November 3, 2015, to review their inventory for the specified lots, discard the kits, and contact the recalling firm for replacement. Certificates of destruction were also provided to customers. For further questions, please call (740) 589-3300.

Device

Device Recall MicroVue SC5b9 Plus EIA (RUO)
  • Model / Serial
    Lot 052418
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) to the states of : CO, CT, IA, IL, MN, MO, NC, NY, OH TX, and UT., and to the countries of : Switzerland, India, Hong Kong, and Japan.
  • Product Description
    MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or 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