Phadia System - ELIA DSDNA (2020-12-14)
- Starting date:
- December 14, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Source of recall:
- Health Canada
- Identification number:
- RA-74657
Last updated: 2020-12-24
Affected Products
A. PHADIA 100 SYSTEM- ELIA DSDNA
B. Phadia 250 System- ELIA DSDNA
Reason
Customer complaints have reported a decrease of values for EliA ANA positive control when using EliA dsDNA well lot bfa3y/0142. An internal investigation showed that EliA dsDNA well lot bfa3y/0142 gives higher results, and in some cases the results may be 3 times higher than other dsDNA well lots. There is potential for a false positive test result.
Affected products
A. PHADIA 100 SYSTEM- ELIA DSDNA
Lot or serial number
BFA3Y/0142
Model or catalog number
14-5500-01
Companies
- Manufacturer
-
PHADIA AB
RAPSGATAN 7, P.O. BOX 6460
UPPSALA
75137
SWEDEN
B. Phadia 250 System- ELIA DSDNA
Lot or serial number
BFA3Y/0142
Model or catalog number
14-5500-01
Companies
- Manufacturer
-
PHADIA AB
RAPSGATAN 7, P.O. BOX 6460
UPPSALA
75137
SWEDEN