October 2021 : Important Product Correction Notification [TC2021-254] - MOD 52 Software Anomalies on ORTHO VISION and ORTHO VISION Max Analyzers
Important Product Correction Notification [TC2021-254] - MOD 52 Software Anomalies on ORTHO VISION and ORTHO VISION Max Analyzers
Affected Medical Device : ORTHO VISION and ORTHO VISION Max Analyzers
MDA Reference Number : MDA/FCA/2021-P155
MDA Registration Number : IVDD33166265118
Decription :
to inform customers who have not yet installed MOD 52 of three (3) software anomalies that could occur during the installation of software MOD 52 for the ORTHO VISION® and ORTHO VISION® Max analysers.
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]
