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ARCHITECT I SYSTEM - ESTRADIOL ASSAY (2016-03-30)
- Starting date:
- March 30, 2016
- Posting date:
- April 7, 2016
- 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-57852
Affected products
A. ARCHITECT I SYSTEM - ESTRADIOL ASSAY
Reason
Reason for the recall is a false increase of estradiol levels in patients treated with Fulvestrant Faslodex) and tested with the ARCHITECT Estradiol assay, list number (LN) 7K72. Nature of defectiveness is the interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant.
Affected products
A. ARCHITECT I SYSTEM - ESTRADIOL ASSAY
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
7K72-20
7K72-25
Companies
- Manufacturer
-
ABBOTT IRELAND DIAGNOSTICS DIVISION
LISNAMUCK, LONGFORD
IRELAND