Events

Recall of BINDAZYME

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Inova Diagnostics Incorporated.

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
    55801
  • Event Risk Class
    Class 3
  • Event Number
    Z-1942-2010
  • Event Initiated Date
    2009-10-28
  • Event Date Posted
    2010-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91848
  • 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
    in vitro diagnostic - Product Code DAK
  • Reason
    The recall was initiated after the binding site notified inova diagnostics, inc. that the affected bindazyme human c1q binding circulating immune complex eia kits may contain an elisa plate labeled as "tissue transglutaminase coated wells" instead of "c1q coated wells".
  • Action
    Notification letters from INOVA Diagnostics Incorporated were mailed to each of the consignees via Certified mail on October 30, 2009. The notification letters inform the consignees of the reason for recall and provided instructions for final disposition of the recalled kits. In addition, a FAX back Attachment was attached to the recall notice for customers to respond to the recall.

Device

BINDAZYME
  • Model / Serial
    Lot numbers: 273005A, 273005B, 273005C, and 273005D
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Germany, Italy, Belgium, Romania, Portugal, Argentina, Spain, Sweden, and India.
  • Product Description
    Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021
  • Manufacturer
    Inova Diagnostics Incorporated

Manufacturer

Inova Diagnostics Incorporated
  • Manufacturer Address
    Inova Diagnostics Incorporated, 9900 Old Grove Rd, San Diego CA 92131-1638
  • Manufacturer Parent Company (2017)
    Werfenlife Sa.
  • Source
    USFDA