5 results
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89ms
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Sources: EU EUDAMED, US FDA
BLOOD BANK COMPUTER SYSTEMS, INC.
FDA registration
BLOOD BANK COMPUTER SYSTEMS, INC.·1 product·🇺🇸 United States
BLOOD BANK CONTROL SYSTEM (BBCS)
FDA Adverse Event
Malfunction
·BLOOD BANK COMPUTER SYSTEMS, INC.·Product code MMH·April 30, 2007
BBCS MOBILE APPLICATION
FDA Adverse Event
Malfunction
·BLOOD BANK COMPUTER SYSTEMS, INC.·Product code MMH·October 1, 2010
BLOOD BANK CONTROL SYSTEM (BBCS)
FDA Adverse Event
Other
·BLOOD BANK COMPUTER SYSTEMS, INC.·Product code MMH·June 13, 1997
GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number 442640; SYNCHRON and UniCel Systems and Part Numbers: Synchron LX20, Part Number: 466200, Synchron LX20 PRO, Part Number: 476100, Synchron LXI 725, Part Number: 476501, UniCel DxC 600, Part Number: A10405, UniCel 600 PRO, Part Number: A11810, UniCel DxC 600i, Part Number: A27318, UniCel DxC 800, Part Number: A11816, UniCel DxC 800 PRO, Part Number: A11812, UniCel DxC 880i, Part Number: A59102, UniCel DxC 660i, Part Number: A64871, UniCel DxC 680i, Part Number: A64903, UniCel DxC860i, Part Number: A64935 (1) The Synchron LX and UniCel DxC Synchron Clinical Systems are fully automated, computer controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (Sample type is chemistry dependent). (2) GLUCm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CEM·August 10, 2010