Health product recall

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

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

ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - POLYMYXIN B

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 533400
  • 533408
Companies
Manufacturer

BioMérieux S.A

376 Chemin De L'orme

Marcy-l'etoile

69280

FRANCE