Events

Recall of Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B

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
    26562
  • Event Risk Class
    Class 3
  • Event Number
    Z-1065-03
  • Event Initiated Date
    2000-02-24
  • Event Date Posted
    2003-07-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27897
  • 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
    Enzyme Linked Immunoabsorbent Assay, Rubella - Product Code LFX
  • Reason
    The high positive control/low positive standard ratio recovering too low.
  • Action
    Recall letters sent out via DHL on 2/24/2000

Device

Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualit...
  • Model / Serial
    Product Number: 514-B (Sigma Diagnostics) Lot Numbers: 020K6491 Exp. 10-02-2001; 090K6483 Exp. 5-31-2002.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The two lots were shipped to St. Louis, MO. No subrecall was initiated.
  • Product Description
    Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B
  • Manufacturer
    Zeus Scientific Inc

Manufacturer

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