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

  1. ARCHITECT c8000 - ANALYZER
  2. ARCHITECT C 16000 - PROCESSING MODULE
  3. ARCHITECT C4000 SYSTEM - PROCESSING MODULE
  4. 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