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U.S. Department of Health and Human Services

Class 2 Device Recall Spectra Optia Apheresis System

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  Class 2 Device Recall Spectra Optia Apheresis System see related information
Date Initiated by Firm December 09, 2010
Date Posted June 28, 2011
Recall Status1 Terminated 3 on September 12, 2011
Recall Number Z-2674-2011
Recall Event ID 58909
510(K)Number K071079  K103090  
Product Classification Separator, automated, blood cell and plasma, therapeutic - Product Code LKN
Product Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215.

The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications. The system may be used to perform Therapeutic Plasma Exchange, Mononuclear Cell Collection, and Red Blood Cell Exchange.
Code Information Serial Numbers: 1P00100 thru 1P00719
Recalling Firm/
Manufacturer		 Caridian BCT, Incorporated
10811 W Collins Ave
Lakewood CO 80215-4440
For Additional Information Contact
303-231-4718
Manufacturer Reason
for Recall		 An additional air detection system is being added to all existing systems to detect air in the system's return line.
FDA Determined
Cause 2		 Software design
Action CaridianBCT sent a "MEDICAL DEVICE RECALL" letter dated December 2010 to all customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were advised to continue using their systems as long as they followed the instructions in the Operator's Manual. An Acknowledgement of Receipt form was included with the letter to be completed and faxed to 1-303-876-9277 or e-mailed to Regulatory.Affairs@caridianbct.com. A CaridianBCT representative will schedule a visit to facilities to upgrade their systems within the next 6 months. Further information is available by contacting the CaridianBCT Support Center at 877-339-4228 or 303-231-4357.
Quantity in Commerce 594 units
Distribution Worldwide Distribution--USA (nationwide) and countries of Australia, Belgium, Canada, China, Hong Kong, Japan, Malaysia, Mexico, Pakistan, Saudi Arabia, Singapore, South Korea, 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.
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