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Etest Ertapenem Foam ETP 32 (2014-02-17)
- Starting date:
- February 17, 2014
- Posting date:
- April 14, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38993
Recalled Products
Etest Ertapenem Foam ETP 32
Reason
The manufacturer identified a performance issue on the Etest foam Ertapenem (Reference number 531610 and 531618) and Etest single pack Ertapenem (Reference number 412332). These strips didn't give the correct MIC (minimum inhibitory concentration) for some of quality control strains.
Affected products
Etest Ertapenem Foam ETP 32
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
412332
531610
531618
Companies
- Manufacturer
-
Biomerieux SA
chemin de l'Orme
Marcy l'Etoile
69280
FRANCE