Jun 2021 : [Important Product Correction Notification] [TC2021-175] - Unexpected Grip Arm & Pipettor Movement in Maintenance Mode on the ORTHO VISIONT and ORTHO VISIONT Max Analyzers
[Important Product Correction Notification] [TC2021-175] - Unexpected Grip Arm & Pipettor Movement in Maintenance Mode on the ORTHO VISIONT and ORTHO VISIONT Max Analyzers
Affected Medical Device : ORTHO VISIONT and ORTHO VISIONT Max Analyzers
MDA Reference Number : MDA/FCA/2021-P089
MDA Registration Number : IVDD33166265118
Decription : an unexpected grip arm or pipett or movement on the ORTHO VISION™ or ORTHO VISION™ Max analysers while in maintenance mode that may cause injury.
Local Establishment Contact Detail :
Siti Noor Liyana Abd Gani
Regulatory Affair and Quality Assurance
DiagnostiCARE Sdn Bhd
No. 1, Jalan Serindit 2, Bandar Puchong Jaya, 47100 Puchong, Selangor, Malaysia.
+603-5882 7011
Email : [email protected]
