[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 : siti.noorliyana@diagnosticare.com.my

 A copy of FSN.