Etest Antimicrobial Susceptibility Testing - Oxac

Starting date:

March 29, 2017

Posting date:

May 16, 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-63204

• Reason
• Affected products

Reason

Based on QC failures (mic out of range high) for S. aureus ATCC 29213 strain on Etest OX 256 (Oxacillin) foam packaging (ref. 520518) reported from the field, Biomerieux initiated a complaint investigation to confirm product issue and determine root cause. The investigation confirmed a potential performance issue for S. Aureus ATCC 29213 QC strain and clinical staphylococcus strains on Etest? OX 256 (Oxacillin) foam packaging (ref. 520518) whatever the media used, when compared to the agar dilution reference method, that could lead to false resistant results. The investigation states that Etest OX 256 (Oxacillin) SPB configuration (ref.412432) performs within the expected specifications.  As a result of the referenced issue, there is a potential performance issue on strain categorization for staphylococcus strains that could lead to major errors when compared to the AD (agar dilution) reference method (resistant result instead of susceptible result) when using 2017 CLSI or 2017 Eucast standards.

Affected products