FSN-2021-013 DR0155M Thermo Scientific™ Campylobacter Test Kit: Auto-agglutinating in all the test latexes with + to ++ reactions.

 

 

Affected Medical Device : 

Campylobacter Test Kit
Model Number: DR0155M
Lot Number: 18512, 18711, 18102, 18003 and 18411

 

MDA Reference Number : MDA/FCA/2021-P176

 

MDA Registration Number : 

Special Access, reference: (8) dlm. MDA.600-3/1/12 Jilid 8, date: 12th April 2019

 

Description :

An internal technical investigation has determined that DR0155M Thermo Scientific™ Campylobacter Test Lots. 18512, 18711, 18102, 18003 and 18411 are auto-agglutinating in all the test latexes with + to ++ reactions.

 

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.