This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFO (2015-06-12)
- Starting date:
- June 12, 2015
- Posting date:
- July 9, 2015
- 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-54158
Recalled Product
A. ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFO
Reason
An internal investigation identified a performance deviation associated with quality control testing of retained product samples indeed the QC results were out of range resulting in false resistant strains.
Affected products
A. ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - CEFO
Lot or serial number
- 1002377890
- 1002590470
- 1002774320
Model or catalog number
505518
Companies
- Manufacturer
-
Biomerieux Sa
Chemin De L'orme
Marcy-l'etoile
69280
FRANCE