Etest Antimicrobial Susceptibility Testing - Erta

Starting date:

April 6, 2017

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-63146

• Reason
• Affected products

Reason

Based on the strain epidemiology evolution with the detection of some streptococcus resistant strains from clinical specimens (around 1 and 5% according to CLSI breakpoints), that did not exist at the moment of the product registration, and as a part of the Etest ETP32 change impact study, bioMerieux initiated an internal study. The investigation results confirmed a potential performance issue on strain categorization for S. viridans group and S. pneumoniae based on 2017 CLSI and EUCAST breakpoints, that could lead to false susceptible result instead of resistant results on Etest ETP32 (Ertapenem) blister packaging when comparing to the broth-micro dilution (BMD) reference method. This performance issue was not evaluated at the time of product registration because rare or no resistant strains were reported at this time.

Affected products