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1,25-Dihydroxy Vitamin D Ria
- Starting date:
- March 14, 2017
- Posting date:
- April 13, 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-63014
Reason
In a small number, approximately 6%, of 1,25-dihydroxy vitamin d ria kits containing calibrators D lot 34649 and E lot 34650, similar CPM values for both calibrators are obtained. These abnormal results lead to an incorrect calibration curve fit.
Affected products
1,25-Dihydroxy Vitamin D Ria
Lot or serial number
- J40007
- J40258
- J40662
- J40785
- J40856
Model or catalog number
- AA-54F1
- AA-54F2
Companies
- Manufacturer
-
Immunodiagnostic Systems Limited
10 Didcot Way, Boldon Business Park,
Boldon, Tyne and Wear,
NE35 9PD
UNITED KINGDOM