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PHADIA 100/250 SYSTEM (2016-04-21)
- Starting date:
- April 21, 2016
- Posting date:
- May 20, 2016
- 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-58530
Affected products
- PHADIA 100 SYSTEM - ELIA CCP
- PHADIA 250 SYSTEM - INSTRUMENT REAGENTS
- PHADIA 250 SYSTEM - ELIA CCP ASSAY
Reason
When using EliA CCP well in combination with EliA IgG conjugate, anti-CCP signals can be elevated. The positive bias will change a small percentage of test results from negative to equivocal and equivocal or high negative to low positive.
Affected products
A. PHADIA 100 SYSTEM - ELIA CCP
Lot or serial number
Not Applicable
Model or catalog number
14-5515-01
83-1040-01
Companies
- Manufacturer
-
PHADIA AB
RAPSGATAN 7
UPPSALA
SWEDEN
B. PHADIA 250 SYSTEM - INSTRUMENT REAGENTS
Lot or serial number
Not Applicable
Model or catalog number
83-1017-01
Companies
- Manufacturer
-
PHADIA AB
RAPSGATAN 7
UPPSALA
SWEDEN
C. PHADIA 250 SYSTEM - ELIA CCP ASSAY
Lot or serial number
Not Applicable
Model or catalog number
14-5515-01
Companies
- Manufacturer
-
PHADIA AB
RAPSGATAN 7
UPPSALA
SWEDEN