5 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code KQO·April 5, 2023
ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
FDA Recall
Open, Classified
·Siemens Healthcare Diagnostics, Inc.·Product code CDQ·August 8, 2023
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
FDA Recall
Open, Classified
·Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland·Product code CDQ·June 13, 2023
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009
FDA Recall
Open, Classified
·LEONI CIA CABLE SYSTEMS 5 avenue Victor Hugo Chartres France·Product code JAI·October 6, 2023
ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003
FDA Recall
Open, Classified
·LEONI CIA CABLE SYSTEMS 5 avenue Victor Hugo Chartres France·Product code JAI·October 6, 2023