Z-0078-2008

Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215

Name: Z-0078-2008 Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215
Creator: Gambro BCT, Inc.
Published: 2007-09-18
License: https://open.fda.gov/license/

Terumo BCT, Ltd / initiated 2007-09-18 / Terminated / root cause: software

FDA source

Gambro BCT, Inc. began a recall of Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215 on 2007-09-18. The reason FDA records is "Under specific conditions, apheresis machine could return up to 60mL of air to the patient". 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-0078-2008
Status: Terminated
Initiated: 2007-09-18
Posted: 2007-10-31
Terminated: 2008-01-25
Recalling firm: Terumo BCT, Ltd
Product: Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.
Product code: LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Reason for recall: Under specific conditions, apheresis machine could return up to 60mL of air to the patient.
Root cause tag: software
FDA root cause: Software design
Action: All consignees were notified by telephone beginning 09/17/2007. They were given instructions on how to safely use the machine. Letters were also sent on 09/22/2007 restating the information.
Quantity in commerce: 15 units
Distribution: US, Canada, Australia, Europe.
Product codes and lots: Part No. 61000, Serial Numbers 1P00100 to 1P00141.

Product code LKN

K071079UnclassifiedSpectra Optia Apheresis System, Spectra Optia Exchange Set, Model 61000, 10200Gambro Bct, Inc. / cleared 2007-08-02

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)