Gambro BCT, Inc. Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.
Brand
Gambro BCT, Inc.
Lot Codes / Batch Numbers
Part No. 61000, Serial Numbers 1P00100 to 1P00141.
Products Sold
Part No. 61000, Serial Numbers 1P00100 to 1P00141.
Gambro BCT, Inc. is recalling Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, C due to Under specific conditions, apheresis machine could return up to 60mL of air to the patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Under specific conditions, apheresis machine could return up to 60mL of air to the patient.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026