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Architect I System – Testosterone Assay
- Starting date:
- January 7, 2013
- Posting date:
- February 4, 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-20197
Recalled Products
A. Architect I System – Testosterone Assay
Reason
Missing product safety information – the current labels and package inserts for the Architect Testosterone Reagent: ln 7K73-20 and 7K73-25, Architect Testosterone Calibrators; ln 7K73-01 and Architect Testosterone Controls; In 7K73-10 do not contain the warnings and precautions applicable to material containing methylisothiazolones which are classified as skin sensitizers.
Affected products
A. Architect I System – Testosterone Assay
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 7K73-01
- 7K73-10
- 7K73-20
- 7K73-25
Companies
- Manufacturer
- Abbott Ireland Diagnostics Division