Field Safety Notice FSN-2021-0006 CT0223B AMC30 Amoxycillin / Clavulanic Acid Antimicrobial Susceptibility Discs

 

Affected Medical Device : AMC30 Amoxycillin / Clavulanic Acid Antimicrobial Susceptibility Discs

 

MDA Reference Number : MDA/FCA/2021-P088

 

MDA Registration Number : IVDB28471108018

 

Decription : An internal investigation by Oxoid Limited, part of Thermo Fisher Scientific, has confirmed that the above lots of CT0223B, ThermoScientificTM OxoidTM Amoxycillin/Clavulanic Acid Antimicrobial Susceptibility Discs, are giving small zones of inhibition for Quality Control organism Escherichia coli ATCC®35218™. The zones of inhibition are outside the specified CLSI/EUCAST 17-22 mm limits.

 

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.