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ARCHITECT C8000 Analyzer, ARCHITECT C16000/C4000 Processing Module and ARCHITECT C4000 Integrated Processing Module (2017-12-13)
- Starting date:
- December 13, 2017
- Posting date:
- December 21, 2017
- 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-65502
Affected products
- ARCHITECT c8000 - ANALYZER
- ARCHITECT C 16000 - PROCESSING MODULE
- ARCHITECT C4000 SYSTEM - PROCESSING MODULE
- ARCHITECT C4000 SYSTEM - INTEGRATED PROCESSING MODULE
Reason
The base of the ARCHITECT Cuvette Segment may become detached under specific conditions. When a cuvette segment base is detached, cuvettes may be seated lower than the designed height. This may result in inadequate dispense into specific cuvettes due to the sample probe being unable to make efficient contact with the cuvette bottom.
Affected products
A. ARCHITECT c8000 - ANALYZER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
01G46-01
Companies
- Manufacturer
-
Abbott Laboratories Diagnostics Division
100 ABBOTT PARK ROAD
ABBOTT PARK
60064
Illinois
UNITED STATES
B. ARCHITECT C 16000 - PROCESSING MODULE
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
09D32-05
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
More than 10 numbers, contact manufacturer.
Model or catalog number
02P75-01
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
More than 10 numbers, contact manufacturer.
Model or catalog number
02P75-01
Companies
- Manufacturer
-
Abbott Laboratories Diagnostics Division
100 ABBOTT PARK ROAD
ABBOTT PARK
60064
Illinois
UNITED STATES