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Roche Hitachi - Salicylate
- Starting date:
- February 2, 2017
- Posting date:
- February 27, 2017
- 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-62376
Reason
During the production of the salicylate reagent, it was noticed that the temperature storage information on the label of the R2 bottle has a wrong storage temperature indication 2-8 degrees celcius instead of 15-25 degrees celcius. The salicylate kit box storage indication is correctly indicated.
Affected products
Roche Hitachi - Salicylate
Lot or serial number
61557101
Model or catalog number
11815172216
Companies
- Manufacturer
-
Roche Diagnostics GMBH
Sandhoferstrasse 116
Mannheim
68305
GERMANY