Class 2 Device Recall Spectra Optia Apheresis System

• Date Initiated by Firm: September 21, 2011
• Date Posted: November 16, 2011
• Recall Status: Terminated on February 01, 2013
• Recall Number: Z-0191-2012
• Recall Event ID: 60174
• 510(K)Number: K071079 K103090
• Product Classification: Separator, automated, blood cell and plasma - Product Code LKN
• Product: Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215.; ; A blood component separator used for therapeutic plasma exchanges.
• Code Information: Serial Numbers: 1P00100 - 1P00XXX
• Recalling Firm/ Manufacturer: Caridian BCT, Incorporated; 10811 W Collins Ave; Lakewood CO 80215-4440
• For Additional Information Contact: 303-239-2241
• Manufacturer Reason for Recall: Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.
• FDA Determined Cause: Software design
• Action: CaridianBCT sent a "Safety Alert" letter dated September 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm will be sending a recall letter to consignees in November 2011, stating they are voluntarily recalling the software and will provide an upgrade once the software has been approved. If you have any further questions please contact your CaridianBCT Representative, the CaridianBCT Support Center at 1-877-3-FYU-BCT ( US Toll free 1-877-299-4228 ) or (303) 231-HELP ) ( 1 (303) 231-4357, or your local CaridianBCT Customer Service office.
• Quantity in Commerce: 852 units (US: 333; Foreign: 519)
• Distribution: Worldwide Distribution -- USA ( nationwide ) and the countries of Australia, Belgium, Canada, Chile, China, Colombia, Hong Kong, India, Japan, Malaysia, Mexico, Pakistan, Republic of Korea, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand and Vietnam.
• 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 = LKN and Original Applicant = CARIDIANBCT, INC.; 510(K)s with Product Code = LKN and Original Applicant = GAMBRO BCT, INC.