Events

Recall of Abbott Clinical Chemistry Bil Cal

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

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
    32959
  • Event Risk Class
    Class 3
  • Event Number
    Z-1400-05
  • Event Initiated Date
    2005-08-05
  • Event Date Posted
    2005-08-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41137
  • 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
    Calibrator, Multi-Analyte Mixture - Product Code JIX
  • Reason
    The product issue is that the value sheet for the clinical chemistry bilirubin calibrator, lot #20881m100 calibrator value sheet, has the calibrator values transposed for the total bilirubin assay ln 7d60, total bilirubin assay ln 8g62, and neonatal bilirubin assay ln 9d88.
  • Action
    A Device Correction letter correcting the transposition of the calibrator values dated August 5, 2005, was mailed to all customers receiving the Clinical Chemistry Bilirubin Calibrator, LN 1E66-03, Lot Number 20881M100.

Device

Abbott Clinical Chemistry Bil Cal
  • Model / Serial
    List # 1E66-03; Lot #20881M100
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Argentian, Brazil, Canada, Cayman, Chile, Columbia, Germany, Hong Kong, Jamaica, New Zealand, Puerto Rico, Singapore, Thailand, Venzuela
  • Product Description
    Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03; Lot # 20881M100
  • Manufacturer
    Abbott Laboratories Diagnostic Div

Manufacturer

Abbott Laboratories Diagnostic Div
  • Manufacturer Address
    Abbott Laboratories Diagnostic Div, 820 Mission St, South Pasadena CA 91030-3142
  • Source
    USFDA