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ZYM B REAGENT (2015-12-23)
- Starting date:
- December 23, 2015
- Posting date:
- February 8, 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-57016
Affected Products
ZYM B REAGENT
Reason
Based on discrepant results (false negative results) reported from the field, bioMérieux initiated a complaint investigation. A loss of performance due to light exposure after 3 months of shelf life for API ZYM B, which lead to false negative results on some API strips using the ZYM B (API 20 Strep-20600, API Coryne-20900, API Staph-20500, API ZYM-25200, API NH-10400, API Listeria-10300).
Affected products
ZYM B REAGENT
Lot or serial number
- 1003765610
- 1003772410
- 1003772470
- 1003787970
- 1003790030
- 1004077210
- 1004097610
- 1004355410
- 1004355730
Model or catalog number
70493
Companies
- Manufacturer
-
Biomerieux Sa
Chemin De L'orme
Marcy-l'etoile
69280
FRANCE