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Immulite 2000 System - Free T3 Assay (2013-08-30)
- Starting date:
- August 30, 2013
- Posting date:
- October 28, 2013
- 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-36433
Recalled Products
Immulite 2000 System - Free T3 Assay
Reason
It was found that there was a positive shift greater than10% at the upper limit of the normal reference range for the Immulite System Free T3 method as the values do not align with the patient clinical picture when interpreted with other thyroid markers.
Affected products
Immulite 2000 System - Free T3 Assay
Lot or serial number
- 737
- 738
- 739
- 740
- 741
- 742
- 743
Model or catalog number
- L2KF32
- L2KF36
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Ltd.
Glyn Rhonwy
Llanberis, Gwynedd
LL55 4EL
UNITED KINGDOM