Events

Recall of Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.

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
    26578
  • Event Risk Class
    Class 3
  • Event Number
    Z-1147-03
  • Event Initiated Date
    2001-06-22
  • Event Date Posted
    2003-08-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-08-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27930
  • 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
    Bacterial contamination of the high positive control.
  • Action
    Recall letter were sent via DHL to consignee on 6/22/2001 which instructed to return or discard any remaining inventory.

Device

Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ ...
  • Model / Serial
    Sigma Product number 552-B; Lot Number 060K6464 Expiration Date: 12-05-2001
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    All product was shipped to St. Louis, MO
  • Product Description
    Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.
  • Manufacturer
    Zeus Scientific Inc

Manufacturer

Zeus Scientific Inc
  • Manufacturer Address
    Zeus Scientific Inc, 200 Evans Way, Branchburg NJ 08876
  • Source
    USFDA