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Immulite and Immulite 2000 Anti-Tg AB Systems and Immulite 1000 System - Thyroid Autoantibody Assay (2014-03-24)
- Starting date:
- March 24, 2014
- Posting date:
- April 14, 2014
- 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-39033
Recalled Products
- Immulite System - Anti-TG AB
- Immulite 2000 System - Anti-TG AB
- Immulite 1000 System - Thyroid Autoantibody Assay
Reason
Siemens Healthcare Diagnostics has confirmed that the Intra-Assay and Inter-Assay Precision of the Immulite/Immulite 1000 and Immulite/Immulite 2000 XPI Anti-TG AB assays does not align with the representative data published in the instructions for use (IFU). Siemens has conducted a "verification of precision performance" study to assess precision. While the concentrations did not exactly match those published in the IFU, the study provides verification that the current precision performance is not in line with the IFU.
Affected products
A. Immulite System - Anti-TG AB
Lot or serial number
- 244
- 245
Model or catalog number
LKTG1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM
B. Immulite 2000 System - Anti-TG AB
Lot or serial number
- 560
- 562
- 564
- 565
- 566
- 567
- 569
- 572
- 574
- 577
Model or catalog number
- L2KTG2
- L2KTG6
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM
C. Immulite 1000 System - Thyroid Autoantibody Assay
Lot or serial number
- 244
- 245
Model or catalog number
LKTG1
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM