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EliA SmDp Well (2015-12-28)
- Starting date:
- December 28, 2015
- Posting date:
- January 28, 2016
- 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-56808
Affected Products
- EliA SmDp Well - PHADIA 250
- EliA SmDp Well - PHADIA 100
Reason
Analysis of patient samples received in complaint investigations showed that several samples caused unspecific signals up to 22 U/mL. The unspecific signals are neither caused by anti-Sm antibodies nor by anti-streptavidin antibodies but are due to other unspecific signals with an as yet unknown cause.
Affected products
A. EliA SmDp Well - PHADIA 250
Lot or serial number
18
Model or catalog number
14-5624-01
Companies
- Manufacturer
-
PHADIA AB
RAPSGATAN 7
UPPSALA
SWEDEN
B. EliA SmDp Well - PHADIA 100
Lot or serial number
18
Model or catalog number
14-5624-01
Companies
- Manufacturer
-
PHADIA AB
RAPSGATAN 7
UPPSALA
SWEDEN