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Health product recall

ADVIA CENTAUR ENHANCED ESTRADIOL (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-56820

Affected Products

  1. ADVIA CENTAUR ENHANCED ESTRADIOL
  2. ADVIA CENTAUR CP SYSTEM ENHANCED ESTRADIOL

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. ADVIA CENTAUR ENHANCED ESTRADIOL

Lot or serial number

ALL

Model or catalog number
  • 10490889
  • 10491445
Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES

B. ADVIA CENTAUR CP SYSTEM ENHANCED ESTRADIOL

Lot or serial number

ALL

Model or catalog number
  • 10490889
  • 10491445
Companies
Manufacturer
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES