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ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - COLI (2016-07-26)
- Starting date:
- July 26, 2016
- Posting date:
- August 19, 2016
- 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-59854
Affected products
- ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - COLI
Reason
Based on scientific publications (including EUCAST warning letter on their website) on colistin gradient and disk diffusion tests, including Etest colistin, bioMerieux was alerted about a potential underestimation of the MIC values for entero bacteriaceae and acinetobacter. bioMerieux initiated a complaint investigation to confirm product performance and determine root cause. While the internal and external investigations are still ongoing.
Affected products
A. ETEST ANTIMICROBIAL SUSCEPTIBILITY TESTING - COLI
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
537300
537308
Companies
- Manufacturer
-
Biomerieux Sa
Chemin De L'orme
Marcy-l'etoile
69280
FRANCE