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Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT (2015-03-20)
- Starting date:
- March 20, 2015
- Posting date:
- May 8, 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-53265
Recalled Products
A. Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT
Reason
Axis-Shield Liquid Stable (LS) 2-Part Homocysteine reagent shows deterioration in assay performance manifesting itself by under recovery of homocysteine in controls and patient samples. The cause of this deterioration has been attributed to a loss of reductant activity in reagent 1.
Affected products
A. Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT
Lot or serial number
802899249
802899989
Model or catalog number
FHRWR100
FHRWR200
Companies
- Manufacturer
-
Axis-Shield Diagnostics Limited
The Technology Park
Dundee
DD2 1XA
UNITED KINGDOM