Field Corrective Action Notification From Thermo Scientific Microbiology Sdn. Bhd. - R30163701 Thermo Scientific™ Remel™ Shigella dysenteriae polyvalent, FSN-2021-012 : R30163701 lot 2971158 is not performing to IFU criteria

 

 

Affected Medical Device : 

Thermo Scientific™ Remel™ Shigella dysenteriae polyvalent
Model Number: R30163701
Lot Number: 2971158

 

MDA Reference Number : MDA/FCA/2021-P159

 

MDA Registration Number : 

SA
(8) dlm. MDA.600-3/1/12 Jilid 8

 

Decription :

An internal technical investigation has determined that R30163701 Shigella dysenteriae polyvalent Lot 2971158 is failing to agglutinate with Sero type 9 and therefore lead to false negative results.

 

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.