ETEST Antimicrobial Susceptibility Testing - Polymyxin B (2017-01-23)

Starting date:

January 23, 2017

Posting date:

February 6, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-65900

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  Reason
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  Affected products

Affected products

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - POLYMYXIN B

Reason

Following a study conducted on ETEST Polymyxin B with 180 clinical strains (Pseudomonas aeruginosa, Acinetobacter and Enterobacteriaceae), an underestimation of the Minimum Inhibitory Concentration (MIC) has been observed for Pseudomonas aeruginosa and Acinetobacter species, compared to those obtained using the Broth Micro-Dilution (BMD) reference method. This has led to false susceptible results when the ETEST Polymyxin B results are interpreted using the Clinical and Laboratory Standards Institute (CLSI) breakpoints

Affected products