Class 3 Device Recall OLA 2500 Olympus Lab Automation System

• Date Initiated by Firm: November 18, 2005
• Date Posted: December 23, 2005
• Recall Status: Terminated on March 10, 2008
• Recall Number: Z-0322-06
• Recall Event ID: 34058
• Product Classification: Calculator/Data Processing Module, For Clinical Use - Product Code JQP
• Product: OLA 2500 Olympus Lab Automation Systems to include the following models (all serial numbers): S2 Full Size, S3 Full Size, Standard Full Size and High Speed Full Size (Aliquoter) manufactured by Olympus Life and Material Science Europa GmbH, Germany and distributed by Olympus America, Inc., 3131 W. Royal Ln., Irving, TX 75063.
• Code Information: Serial Numbers: 93, 96, 112, 114, 1014 and 1054. Serial numbers correspond to units currently in distribution.
• FEI Number: 3002406108
• Recalling Firm/ Manufacturer: Olympus America, Inc; 3131 W Royal Ln; Irving TX 75063-3104
• Manufacturer Reason for Recall: Lab Automation System may dilute samples with water.
• FDA Determined Cause: Other
• Action: Firm initiated recall on 11/18/05 via letter to all direct accounts.
• Quantity in Commerce: 6 total units.
• Distribution: Nationwide; Distribution was made to laboratories and blood centers located in CA, CO, GA, NC, and OH.
• 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.