Health product recall

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