October 2021 : Field Corrective Action Notification QC-11-02 - DR0704G Pathodxtra Strep Group D Latex FSN-2021-010 : Lots 3312966 & 3312967 are not performing to IFU criteria.
Field Corrective Action Notification QC-11-02 - DR0704G Pathodxtra Strep Group D Latex FSN-2021-010 : Lots 3312966 & 3312967 are not performing to IFU criteria.
Affected Medical Device :
Pathodxtra Strep Group D Latex
Model Number: DR0704G
Lot Number: 3312966, 3312967
MDA Reference Number : MDA/FCA/2021-P145
MDA Registration Number : IVDB73391327618
Decription : An internal investigation has found that DR0704G lots 3312966 & 3312967 are not performing to IFU criteria.
Local Establishment Contact Detail :
Gan May Ping
Quality Manager
Thermo Scientific Microbiology Sdn. Bhd.
No. 6, Jalan TTC 6, Taman Teknologi Cheng, 75250 Cheng, Melaka, Malaysia.
606 -334 0975
Email : [email protected]
