[Important Product Correction Notification][TC2021-174] - VITROS Systems Inadvertently Configured to Use Expired Reagent

 

Affected Medical Device : VITROS®3600 Immunoassay Systems and VITROS®5600/XT 7600 Integrated Systems

 

MDA Reference Number : MDA/FCA/2021-P094

 

MDA Registration Number : IVDA91605293118

 

Decription : inadvertently left after a service call with a configuration that allows the use of expired reagents

 

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.