Etest Antimicrobial Susceptibility Testing - CEFU

Starting date:

February 24, 2016

Posting date:

February 14, 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-62196

• Reason
• Affected products

Reason

An analysis was performed on the essential agreement rate reflecting the mic result obtained by the product for a significant strains kit including Enterobacteriaceae, Haemophilus and Streptococcus pneumonia species. An additional analysis was done on the clinical categorization of the strains based on Clinical and Laboratory Standards Institute (CLSI) Guidelines.

The following have been identified:

• The investigation confirmed a potential performance issue on strains categorization for Streptococcus pneumoniae and for Enterobacteriaceae strains limited to oral Cefuroxim breakpoints and based on 2016 CLSI clinical standards only.
• For Streptococcus pneumoniae on Etest Cefuroxime XM 256 Foam and SPB that could lead to minor error on clinical strains : false susceptible result instead of intermediate results with BMD (broth micro dilution) reference method.
• False intermediate result instead of resistant results with BMD reference method for Enterobacteriaceae on Etest Cefuroxime XM 256 Foam and SPB that could lead to minor error on clinical strains : false susceptible result instead of intermediate results with AD (agar dilution) reference method.
• False intermediate result instead of resistant results with ad reference method products perform within the specification when using the 2016 EUCAST Guidelines.

Affected products