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  • Jun 2021 : [Important Product Correction Notification][TC2021-174] - VITROS Systems Inadvertently Configured to Use Expired Reagent

Jun 2021 : [Important Product Correction Notification][TC2021-174] - VITROS Systems Inadvertently Configured to Use Expired Reagent

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

 

Affected Medical Device : VITROSĀ®3600 Immunoassay Systems and VITROSĀ®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.

Cetak

  Pihak Berkuasa Peranti Perubatan Malaysia,
Kementerian Kesihatan Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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  • Kemaskini Terakhir: 20 Oktober 2021.
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