Siemens' various Immulite Systems (2017-12-18)
- Starting date:
- December 18, 2017
- Posting date:
- January 8, 2018
- 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-65582
Affected Products
A. IMMULITE SYSTEM-OM-MA TUMOUR MARKER CA 125
B. IMMULITE SYSTEM- BR-MAT. MARKER CA 15.3 ASSAY
C. IMMULITE SYSTEM- CK-MB ASSAY
D. IMMULITE SYSTEM- THYROGLOBULIN ASSAY
E. IMMULITE 2000 SYSTEM- OM-MA ASSAY
F. IMMULITE SYSTEM- CEA ASSAY
G. IMMULITE 1000 SYSTEM- GASTRIN ASSAY
H. IMMULITE 1000 SYSTEM- VITAMIN B12 ASSAY
I. IMMULITE 2000 SYSTEM- GASTRIN ASSAY
J. IMMULITE SYSTEM - VITAMIN B12 ASSAY
K. IMMULITE 2000 SYSTEM- BR-MA ASSAY
L. IMMULITE 2000 SYSTEM- CK-MB ASSAY
M. IMMULITE 1000 SYSTEM- CEA ASSAY
N. IMMULITE 1000 SYSTEM- BR-MA ASSAY
O. IMMULITE 1000 SYSTEM- THYROGLOBULIN ASSAY
P. IMMULITE 1000 SYSTEM- OM-MA ASSAY
Q. IMMULITE 2000 SYSTEM- CEA ASSAY
R. IMMULITE 2000 SYSTEM-3GALLERY SPECIFIC IGE ASSAY
S. IMMULITE 2000 SYSTEM- FOLIC ACID ASSAY
T. IMMULITE 2000 SYSTEM- ANTI-HBC ASSAY
U. IMMULITE SYSTEM- ERYTHROPOIETIN (EPO) ASSAY
V. IMMULITE 1000 SYSTEM- ERYTHROPOIETIN (EPO) ASSAY
W. IMMULITE 2000 SYSTEM- ERYTHROPOIETIN (EPO) ASSAY
Reason
Siemens Healthcare Diagnostics has confirmed through internal investigation that the Immulite/Immulite 1000/Immulite 2000/Immulite 2000 XPI Assays (listed) are susceptible to biotin interference. This occurs when biotin present in patient samples interferes with the Biotin-Streptavidin Assay architecture on the Immulite platform. Biotin interference has the potential to bias analytical results on the assays listed above. The Instructions For Use (IFU) currently do not list biotin as a potential interferant.
Affected products
A. IMMULITE SYSTEM-OM-MA TUMOUR MARKER CA 125
Lot or serial number
Not applicable
Model or catalog number
LKOP1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
B. IMMULITE SYSTEM- BR-MAT. MARKER CA 15.3 ASSAY
Lot or serial number
Not applicable
Model or catalog number
LKBR1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
C. IMMULITE SYSTEM- CK-MB ASSAY
Lot or serial number
Not applicable
Model or catalog number
LKMB1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
D. MMULITE SYSTEM- THYROGLOBULIN ASSAY
Lot or serial number
Not applicable
Model or catalog number
LKTY1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
E. IMMULITE 2000 SYSTEM- OM-MA ASSAY
Lot or serial number
Not applicable
Model or catalog number
L2KOP2
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
F. IMMULITE SYSTEM- CEA ASSAY
Lot or serial number
Not applicable
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
G. IMMULITE 1000 SYSTEM- GASTRIN ASSAY
Lot or serial number
Not applicable
Model or catalog number
LKGA1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
H. IMMULITE 1000 SYSTEM- VITAMIN B12 ASSAY
Lot or serial number
Not applicable
Model or catalog number
LKVB1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
I. IMMULITE 2000 SYSTEM- GASTRIN ASSAY
Lot or serial number
Not applicable
Model or catalog number
L2KGA2
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
J. IMMULITE SYSTEM - VITAMIN B12 ASSAY
Lot or serial number
Not applicable
Model or catalog number
LKVB1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
K. IMMULITE 2000 SYSTEM- BR-MA ASSAY
Lot or serial number
Not applicable
Model or catalog number
L2KBR2
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
L. IMMULITE 2000 SYSTEM- CK-MB ASSAY
Lot or serial number
Not applicable
Model or catalog number
L2KMB2
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
M. IMMULITE 1000 SYSTEM- CEA ASSAY
Lot or serial number
Not applicable
Model or catalog number
LKCE1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
N. IMMULITE 1000 SYSTEM- BR-MA ASSAY
Lot or serial number
Not applicable
Model or catalog number
LKBR1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
O. IMMULITE 1000 SYSTEM- THYROGLOBULIN ASSAY
Lot or serial number
Not applicable
Model or catalog number
LKTY1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
P. IMMULITE 1000 SYSTEM- OM-MA ASSAY
Lot or serial number
Not applicable
Model or catalog number
LKOP1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
Q. IMMULITE 2000 SYSTEM- CEA ASSAY
Lot or serial number
Not applicable
Model or catalog number
L2KCE2
L2KCE6
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
R. IMMULITE 2000 SYSTEM-3GALLERY SPECIFIC IGE ASSAY
Lot or serial number
Not applicable
Model or catalog number
L2KUN6
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
S. IMMULITE 2000 SYSTEM- FOLIC ACID ASSAY
Lot or serial number
Not applicable
Model or catalog number
L2KFO2
L2KFO6
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
T. IMMULITE 2000 SYSTEM- ANTI-HBC ASSAY
Lot or serial number
Not applicable
Model or catalog number
L2KHC2
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
U. IMMULITE SYSTEM- ERYTHROPOIETIN (EPO) ASSAY
Lot or serial number
Not applicable
Model or catalog number
LKEPN1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
V. IMMULITE 1000 SYSTEM- ERYTHROPOIETIN (EPO) ASSAY
Lot or serial number
Not applicable
Model or catalog number
LKEPN1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
W. IMMULITE 2000 SYSTEM- ERYTHROPOIETIN (EPO) ASSAY
Lot or serial number
Not applicable
Model or catalog number
L2KEPN2
L2KEPN6
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM