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Architect I System - Total T3 Assay (2014-09-15)
- Starting date:
- September 15, 2014
- Posting date:
- September 22, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-41455
Recalled products
- Architect I System - Total T3 Assay
Reason
Two reagent lots may exhibit lower relative light units (RLUS) than expected, which in turn may result in controls out of range or patient results higher than expected.
Affected products
A. Architect I System - Total T3 Assay
Lot or serial number
- 38901UI00
- 38901UI01
Model or catalog number
- 7K64-20
- 7K64-25
Companies
- Manufacturer
-
Abbott Ireland Diagnostics Division
lisnamuck, longford,
IRELAND