Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.
FDA Recall Z-0191-2012 · Posted 2011-11-16
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Recalling FirmCaridian BCT, Incorporated
Recall StatusTerminated
Product CodeLKN
Date Initiated2011-09-21
Date Terminated2013-02-01
Product Quantity852 units (US: 333; Foreign: 519)
Reason for Recall
Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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