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Devices
Spectra Optia
Model / Serial
Part No. 61000, Serial Numbers 1P00100 to 1P00141.
Product Classification
Gastroenterology-Urology Devices
Device Class
Unclassified
Implanted device?
No
Distribution
US, Canada, Australia, Europe.
Product Description
Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.
Manufacturer
Gambro BCT, Inc.
1 Event
Recall of Spectra Optia
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Manufacturer
Gambro BCT, Inc.
Manufacturer Address
Gambro BCT, Inc., 10811 W Collins Ave, Lakewood CO 80215-4440
Source
USFDA
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