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IMMULITE SYSTEMS - ESTRADIOL ASSAYS (2016-01-14)
- Starting date:
- January 14, 2016
- Posting date:
- January 25, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-56824
Affected Products
- IMMULITE SYSTEM - ESTRADIOL ASSAY
- IMMULITE 2000 SYSTEM - ESTRADIOL ASSAY
- IMMULITE 1000 SYSTEM - ESTRADIOL ASSAY
Reason
Siemens Healthcare Diagnostics is conducting a correction for all lots of ADVIA Centaur Enhanced Estradiol, Dimension Vista LOCI Estradiol, IMMULITE/IMMULITE 1000 Estradiol and IMMULITE 2000 Estradiol. Siemens has confirmed the drug fulvestrant (FASLODEX) may cause falsely elevated estradiol results in the assays listed.
Affected products
A. IMMULITE SYSTEM - ESTRADIOL ASSAY
Lot or serial number
ALL
Model or catalog number
LKE21
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
B. IMMULITE 2000 SYSTEM - ESTRADIOL ASSAY
Lot or serial number
ALL
Model or catalog number
- L2KE22
- L2KE26
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM
C. IMMULITE 1000 SYSTEM - ESTRADIOL ASSAY
Lot or serial number
ALL
Model or catalog number
LKE21
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Products Limited
Glyn Rhonwy
Llanberis
LL55 4EL
UNITED KINGDOM