Class 2 Device Recall

• Date Initiated by Firm: June 17, 2001
• Date Posted: July 20, 2004
• Recall Status: Terminated on January 04, 2005
• Recall Number: Z-1117-04
• Recall Event ID: 27396
• Product Classification: Albumin, Antigen, Antiserum, Control - Product Code DCF
• Product: Aeroset Prealbumin Reagent, LN 1E02-01
• Code Information: Reagent Application sheet number 30-2442/R5/May 2000
• FEI Number: 2018433
• Recalling Firm/ Manufacturer: Abbott Laboratories Diagnostic Div; 820 Mission Street; South Pasadena CA 91030
• Manufacturer Reason for Recall: False Positive results possible.
• FDA Determined Cause: Other
• Action: The firm issued a new piece of labeling and sent them to customers requesting that the old version be removed and replaced with the new version.
• Quantity in Commerce: 161
• Distribution: Nationwide and to Argentina, Australia, Brazil, Germany, England, Canada, Chile, Columbia, Dominican Republic, Denmark, France, Hong Kong, Japan, Korea, Singapore, Guatemala, New Zealand, Thailand, Turkey, Spain, Italy, South Africa, Sweden, Greece, Portugal, Venezuela, Pakistan, Finland, Ireland, Taiwan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.