Class 3 Device Recall

• Date Initiated by Firm: June 04, 2003
• Date Posted: August 21, 2003
• Recall Status: Terminated on June 17, 2014
• Recall Number: Z-1149-03
• Recall Event ID: 26431
• 510(K)Number: K003677
• Product Classification: Counter, Differential Cell - Product Code GKZ
• Product: ABX Diagnostices Pentra 60C+ Hematology Analyzer
• Code Information: Software versions of up to 1.7
• FEI Number: 3002698356
• Recalling Firm/ Manufacturer: ABX Diagnostics Inc; 34 Bunsen Drive; Irvine CA 92618
• For Additional Information Contact: Tom Phillips; 949-453-0500 Ext. 233
• Manufacturer Reason for Recall: Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.
• FDA Determined Cause: Other
• Action: The firm distributed a 'Product Advisory Note' on June 5, 2003 by mail which includes instructions on how to avoid problems. It also mentions a new software release which will fix the problem.
• Quantity in Commerce: 159
• Distribution: Nationwide.
• 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.

• 510(K) Database: 510(K)s with Product Code = GKZ