Events

Recall of Device Recall Abbott Clinical Chemistry Albumin BCG (AlbG)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories 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
    55440
  • Event Risk Class
    Class 2
  • Event Number
    Z-1434-2012
  • Event Initiated Date
    2010-03-10
  • Event Date Posted
    2012-04-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90864
  • 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
    Bromcresol green dye-binding, albumin - Product Code CIX
  • Reason
    Observed particulate matter in some reagent cartridges.
  • Action
    Abbott Laboratories sent a Product Recall notification letter dated March 10, 2010, to all affected customers. The notification letter contained an explanation, patient impact, neccassary actions, and contact information. Customers were instructed to determine if they currently have any of the affected product in their inventory. Discontinue use and destroy any remaining inventory of the affected product in accordance with their institution's policies and procedures. Completed the enclosed Customer Reply Form. If customers forwarded any of the affected product they should provide a copy of the notification letter to their customers. For any questions customers should call Customer Service at 1-877-422-2688. For questions regarding this recall call 626-440-0705.

Device

Device Recall Abbott Clinical Chemistry Albumin BCG (AlbG)
  • Model / Serial
    Lot Numbers: 77056HW00; 80051HW00; 83030HW00 Exp dates: 04/15/2011, 07/15/2011, and 10/10/2011, respectively.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US nationwide and internationally to Germany, Hong Kong, Australia, New Zealand, Trinidad/Tobago, and Jamaica. No dsitribution of Canada or Mexica.
  • Product Description
    Clinical Chemistry Albumin BCG (AlbG) List Number 7D53-21 || Clinical Chemistry Albumin BCG 510(k) K981758, Product Code CIX || The Albumin BCG assay is used for the quantitation of albumin in human serum or plasma
  • Manufacturer
    Abbott Laboratories Inc.

Manufacturer

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