ARCHITECT, Alinity i Estradiol Reagent Kits (2019-02-09)
- Starting date:
- February 9, 2019
- Posting date:
- February 22, 2019
- 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-69124
Affected Products
- ARCHITECT Estradiol Reagent Kit
- Alinity i Estradiol Reagent Kit
Reason
Interaction between Mifepristone and the ARCHITECT and Alinity i Estradiol assays may result in falsely elevated Estradiol results.
Affected products
A. ARCHITECT Estradiol Reagent Kit
Lot or serial number
- 89225UI00
- 90185UI00
- 91454UI00
- 93011UI00
- 93520UI00
- 93537UI00
- 94074UI00
- 94285UI00
- 95176UI00
Model or catalog number
- 7K72-25
- 7K72-35
Companies
- Manufacturer
-
Abbott Ireland Diagnostic Division
Lisnamuck, Longford
IRELAND
B. Alinity i Estradiol Reagent Kit
Lot or serial number
- 91459UI00
- 94291UI00
Model or catalog number
- 07P5020
- 07P5030
Companies
- Manufacturer
-
Abbott Ireland Diagnostic Division
Lisnamuck, Longford
IRELAND