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AMMONIA (2015-01-19)
- Starting date:
- January 19, 2015
- 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-55754
Affected Products
AMMONIA
Reason
Patient samples will recover with a positive bias of approximately 60 µmol/L when using ammonia catalogue numbers: AM1015 batch: 326173, AM1054 batch: 326180, AM8112 batch: 326186. This issue will not be evident in the control material being used.
Affected products
AMMONIA
Lot or serial number
326173
Model or catalog number
AM1015
Companies
- Manufacturer
-
Randox Laboratories Ltd.
55 Diamond Road
Ardmore, County Antrim
BT29 4QY
UNITED KINGDOM