Events

Recall of Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.

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
    26516
  • Event Risk Class
    Class 3
  • Event Number
    Z-1031-03
  • Event Initiated Date
    2001-11-09
  • Event Date Posted
    2003-07-19
  • 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=27817
  • 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, Rheumatoid Factor - Product Code DHR
  • Reason
    Calibrator c not meeting its optical density specification.
  • Action
    Customers were notified of the recall via DHL on 11/9/2001. Customers were instructed to return or destroy product.

Device

Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Sa...
  • Model / Serial
    Product Number: 507-B (Sigma Diagnostics) Lot Number: 090K6499 Expiration Date: 5-31-2002.  Product Number: 2Z921M (Zeus) Lot Number: 00010446 Expiration Date: 06-09-2002
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The Sigma product was shipped to Sigma directly. The Zeus product was shipped to customers nationwide via DHL. Zeus customers consists of hospitals, and clinical laboratories.
  • Product Description
    Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.
  • Manufacturer
    Zeus Scientific Inc

Manufacturer

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