Z-0191-2012

Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator...

Name: Z-0191-2012 Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator...
Creator: Caridian BCT, Incorporated
Published: 2011-09-21
License: https://open.fda.gov/license/

Terumo BCT, Ltd / initiated 2011-09-21 / Terminated / root cause: software

FDA source

Caridian BCT, Incorporated began a recall of Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges on 2011-09-21. The reason FDA records is "Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0191-2012
Status: Terminated
Initiated: 2011-09-21
Posted: 2011-11-16
Terminated: 2013-02-01
Recalling firm: Terumo BCT, Ltd
Product: Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.
Product code: LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Reason for recall: Possible higher than expected platelet loss following therapeutic plasma exchange or plasmapheresis.
Root cause tag: software
FDA root 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.
Product codes and lots: Serial Numbers: 1P00100 - 1P00XXX

Product code LKN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)