ETEST Antimicrobial Susceptibility Testing - Teicoplanin (2017-12-14)

Starting date:

December 14, 2017

Posting date:

January 12, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-65646

• 
  Reason
• 
  Affected products

Affected products

ETEST Antimicrobial Susceptibility Testing - Teicoplanin

Reason

Following an assessment of ETEST Teicoplanin with Staphylococcus Spp., It has been observed that even though the Minimum Inhibitory Concentration (MIC) essential agreement at +/- 1 dilution is less than 95% between ETEST TP256 and the reference method Agar Dilution (AD) for Staphylococcus Spp., an underestimation of MIC values by at least 1 dilution has been observed for coagulase negative Staphylococci (cons). This underestimation leads to a risk of false susceptible results linked, in particular to the lack of an intermediate category interpretation if EUCAST breakpoints are applied for this antibiotic. During the study, the false susceptible rate observed was 37.5% for cons, where strains with an MIC at 8 mg/ml, by the reference method (resistant) can be found susceptible by ETEST Teicoplanin.

Affected products