[TC2021-192] [Follow Up: Urgent Product Correction] [Availability of Application Software Version 5.13.4 Modification (MOD) 58 & 0.5M NaOH Usage Guidelines for ORTHO VISIONR and ORTHO VISIONR Max Analyzer]

 

 

Affected Medical Device : ORTHO VISION® and ORTHO VISION® Max Analyser

 

MDA Reference Number : MDA/FCA/2021-P181

 

MDA Registration Number : IVDD33166265118

 

Description :

This software is further corrective action for the issue identified in customer letters (CL2020-206 and CL2021-110) regarding the potential for intermittent false positive results being generated when processing ORTHO Sera anti-D (IAT) and Indirect Antiglobulin Test (IAT) crossmatch (XM) tests after pipetting high titre plasma or serum samples. This potential is also reduced by the decontamination procedure described in the Release Notes and enclosed NaOH Guideline.

 

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.