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 : may-ping.gan@thermofisher.com

 A copy of FSN.