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Immulite, Immulite1000 and Immulite 2000 Systems (2014-12-29)
- Starting date:
- December 29, 2014
- Posting date:
- January 7, 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-43105
Recalled Products
A) Immulite System-CEA Assay
B) Immulite 1000 System-CEA Assay
C) Immulite 2000 System-CEA Assay
Reason
Siemens internal investigation confirmed that the Immulite/Immulite 1000 and the Immulite 2000/ 2000 XPi CEA assay does not meet the (within-run precision specifications as per the Immulite/Immulite 1000 and the Immulite 2000/ 2000 XPi IFU's for all in date Immulite CEA kit lots. The Immulite/Immulite 1000 and the Immulite 2000/ 2000 XPi CEA inter-assay (total precision) shows equivalence to the IFU and is therefore not impacted by this issue.
Affected products
A) Immulite System-CEA Assay
Lot or serial number
All lots.
Model or catalog number
LKCE1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM
B) Immulite 1000 System-CEA Assay
Lot or serial number
All lots.
Model or catalog number
LKCE1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM
C) Immulite 2000 System-CEA Assay
Lot or serial number
All lots.
Model or catalog number
L2KCE2
L2KCE6
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM