Events

Recall of Device Recall IMx Rubella IgM Reagent Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories HPD/ADD/GPRD.

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
    26868
  • Event Risk Class
    Class 3
  • Event Number
    Z-1129-03
  • Event Initiated Date
    2003-07-22
  • Event Date Posted
    2003-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28610
  • 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 package insert contains incomplete information for the english text. pages 4 and 5 are missing and pages 14 and 15 are duplicated.
  • Action
    Recall letters dated 7/21/03 were sent to the accounts by Federal Express Priority on 7/22/03, informing the accounts of the error in the package insert and instructing them to discontinue using the incorrect insert (commodity 34-0284/R8) and used the enclosed revised insert (commodity 34-2915/R9) with lot 01687M300. The revised package insert 34-2915/R9 was inadvertently omitted from the first mailing and was sent on 7/23/03.

Device

Device Recall IMx Rubella IgM Reagent Kit
  • Model / Serial
    list 7A24-20, lot 01687M300
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California, Michigan, North Carolina, Ohio, Tennessee, Wisconsin, Georgia, Illinois, Kentucky, Massachusetts and Texas, and internationally to Columbia, Peru, Uruguay, Brazil, San Salvador, Canada, Germany, Singapore, Korea and Honduras
  • Product Description
    IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
    Abbott Laboratories HPD/ADD/GPRD

Manufacturer

Abbott Laboratories HPD/ADD/GPRD
  • Manufacturer Address
    Abbott Laboratories HPD/ADD/GPRD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA