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ZYM B Reagent and API Biomedical Tests (2013-11-12)
- Starting date:
- November 12, 2013
- Posting date:
- January 13, 2014
- 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-37459
Recalled products
- ZYM B Reagent
- API NH
- API Listeria
Reason
Investigations confirmed an activity issue on Zym B reagent whatever the color of Zym B ampule. This activity issue lead to a false negative result of some API biochemical tests using the Zym B reagent.
Affected products
A. ZYM B Reagent
Lot or serial number
- 1001951820
- 1002011320
- 1002071020
- 1002171010
- 1002295110
- 1002360360
- 1002421440
- 1002485410
Model or catalog number
- 70493
Companies
- Manufacturer
-
Biomerieux SA
chemin de l'Orme
Marcy l'Etoile
69280
FRANCE
B. API NH
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 10400
Companies
- Manufacturer
-
Biomerieux SA
chemin de l'Orme
Marcy l'Etoile
69280
FRANCE
C. API Listeria
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 10300
Companies
- Manufacturer
-
Biomerieux SA
chemin de l'Orme
Marcy l'Etoile
69280
FRANCE