Events

Recall of Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test kit which is coated with the appropirate antigen, are placed in a foil pouch, which is also placed in the middle of the cardboard box.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zeus Scientific 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
    29963
  • Event Risk Class
    Class 3
  • Event Number
    Z-0214-05
  • Event Initiated Date
    2004-08-30
  • Event Date Posted
    2004-11-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34853
  • 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
    System, Test, Anticardiolipin Immunological - Product Code MID
  • Reason
    During packaging, lyme plates were packaged in this kit in error.
  • Action
    Wampole Laboratories was contacted by Zeus on 8/30/3004. Wampole customers were then contacted by phone and letter to destroy all products on hand.

Device

Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plat...
  • Model / Serial
    Lot 04027128 exp 2005-10
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    25 units were sent directly from Zeus to their direct account Wampole Laboratories. The distributor contacted their customers to discard all affected kits. 8 units were shipped overseas to Israel. There were no ships to government facilities.
  • Product Description
    Cardiolipin IgM ELISA Test System, Product Number 438450CE. The test kit consists of a test plate, and various reagents in individual vials (positive and negative controls, calibrator, diluent, substrate, stop solution, wash buffer.). The individual vials are secured in the card board box. The test kit which is coated with the appropirate antigen, are placed in a foil pouch, which is also placed in the middle of the cardboard box.
  • Manufacturer
    Zeus Scientific Inc

Manufacturer

Zeus Scientific Inc
  • Manufacturer Address
    Zeus Scientific Inc, 200 Evans Way, Somerville NJ 08876-3767
  • Source
    USFDA