ARCHITECT Total and Free T3 Reagent Kit (2018-10-16)
- Starting date:
- October 16, 2018
- Posting date:
- November 2, 2018
- 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-68164
Affected products
- ARCHITECT Total T3 Reagent Kit
- ARCHITECT Free T3 Reagent Kit
- ARCHITECT Free T3 Reagent Kit
- ARCHITECT Total T3 Reagent Kit
Reason
During non-conformance investigation a Reagent Cross Contamination (RCC) has been observed for the 6 and 2-point ARCHITECT Free T3 and Total T3 assays on the i1000, when tested alongside assays containing Poly-L-Lysine (PLL) e.g. ARCHITECT TSH.
RCC has also been observed for the 2 and 6-point ARCHITECT Free T3 and Total T3 assays when tested on the i2000/i2000SR system and the Alinity i System.
Affected products
A. ARCHITECT Total T3 Reagent Kit
Lot or serial number
All lots.
Model or catalog number
- 7K64-20
- 7K64-25
- 7K64-30
- 7K64-35
Companies
- Manufacturer
-
Abbott Ireland Diagnostic Division
Lisnamuck, Longford
IRELAND
B. ARCHITECT Free T3 Reagent Kit
Lot or serial number
All lots.
Model or catalog number
- 7K63-20
- 7K63-25
- 7K63-30
- 7K63-35
Companies
- Manufacturer
-
Abbott Ireland Diagnostic Division
Lisnamuck, Longford
IRELAND
C. ARCHITECT Free T3 Reagent Kit
Lot or serial number
All lots.
Model or catalog number
- 7K63-27
- 7K63-32
- 7K63-37
Companies
- Manufacturer
-
Abbott Ireland Diagnostic Division
Lisnamuck, Longford
IRELAND
D. ARCHITECT Total T3 Reagent Kit
Lot or serial number
All lots.
Model or catalog number
- 7K64-27
- 7K64-32
- 7K64-37
Companies
- Manufacturer
-
Abbott Ireland Diagnostic Division
Lisnamuck, Longford
IRELAND