Field Corrective Action Notification From Thermo Scientific Microbiology Sdn. Bhd. - R8311005 Remel RapID NF Plus System FSN-2021-0007

 

Affected Medical Device : 

Remel RapID NF Plus System
Part Number: R8311005
Lot Number: 158548, 143096, 158586, 168222 and 168235

 

MDA Reference Number : MDA/FCA/2021-P129

 

MDA Registration Number : IVDB22180261018

 

Decription : A technical investigation has determined ATCC 19606 (Acinetobacter baumannii ATCC® 19606), ATCC 13253 (Elizabethkingia menigoseptica ATCC® 13253) and blank (NF reagent) gave a positive reaction where it should have given a negative reaction within the NO3 well of the panel.

 

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.