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AMMONIA ULTRA REAGENT (2015-09-28)
- Starting date:
- September 28, 2015
- Posting date:
- October 22, 2015
- 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-55506
Affected Products
AMMONIA ULTRA REAGENT
Reason
Due to a manufacturing issue with ammonia ultra reagent, List Number 6K89-30, Lot 50083Y600 is being removed from use. This lot is producing results below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes. Quality control results are not affected.
Affected products
AMMONIA ULTRA REAGENT
Lot or serial number
50083Y600
50083Y600 EXPIRY 31 JULY 2016
Model or catalog number
6K89-30
Companies
- Manufacturer
-
Sentinel Ch Spa
Via Robert Koch, 2
Milan
20152
ITALY