ARCHITECT System - Analyzer - Class 2, ARCHITECT c4000 and c16000 Processing Modules, ARCHITECT c4000 System - Integrated Processing Module (2019-05-02)
- Starting date:
- May 2, 2019
- Posting date:
- May 17, 2019
- 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-69970
Last updated: 2019-05-17
Affected Products
A. ARCHITECT System - Analyzer - Class 2
B. ARCHITECT c16000 - Processing Module
C. ARCHITECT c4000 System - Processing Module
D. ARCHITECT c4000 System - Integrated Processing Module
Reason
This Product Correction letter is to inform you of an issue with the ARCHITECT c Systems Mixer (LN 09D59-01, 09D59-02, and 09D59-03). There is the potential for the mixer blade, attached to the mixer with a screw and nut, to separate from the mixer. The missing mixer blade will result in inadequate mixing of the reaction mixtures leading to potential incorrect results (failed assay calibration, Quality Control (QC) out of range, and/or incorrect patient results). The impact on the test result may vary depending on the assay being performed and the viscosity of the patient sample.
Affected products
A. ARCHITECT System - Analyzer - Class 2
Lot or serial number
All lots.
Model or catalog number
01G06-01
01G06-11
Companies
- Manufacturer
-
Abbott Laboratories Diagnostics Division
100 ABBOTT PARK ROAD
ABBOTT PARK
60064
Illinois
UNITED STATES
B. ARCHITECT c16000 - Processing Module
Lot or serial number
All lots.
Model or catalog number
03L77-01
Companies
- Manufacturer
-
Abbott Laboratories Diagnostics Division
100 ABBOTT PARK ROAD
ABBOTT PARK
60064
Illinois
UNITED STATES
C. ARCHITECT c4000 System - Processing Module
Lot or serial number
All lots.
Model or catalog number
02P24-01
Companies
- Manufacturer
-
Abbott Laboratories Diagnostics Division
100 ABBOTT PARK ROAD
ABBOTT PARK
60064
Illinois
UNITED STATES
D. ARCHITECT c4000 System - Integrated Processing Module
Lot or serial number
All lots.
Model or catalog number
02P24-40
Companies
- Manufacturer
-
Abbott Laboratories Diagnostics Division
100 ABBOTT PARK ROAD
ABBOTT PARK
60064
Illinois
UNITED STATES