Health product recall

Alere Afinion AS100 Analyzer & Alfinion 2 (2020-03-22)

Starting date:
March 22, 2020
Posting date:
April 17, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72817



Last updated: 2020-04-17

Affected Products

  1. Alere Afinion AS100 Analyzer
  2. Afinion 2

Reason

Abbott has received complaints related to electrostatic discharge and sparking of the power supply provided with the analyzers. Customers have experienced power supplies becoming non-functional after these events.

Affected products

A. Alere Afinion AS100 Analyzer

Lot or serial number

All lots.

Model or catalog number

1116069

Companies
Manufacturer

ABBOTT DIAGNOSTIC TECHNOLOGIES AS

KJELSASVEIEN 161, P.O. BOX 6863 RODELOKKA

OSLO

504

NORWAY


B. Afinion 2

Lot or serial number

All lots.

Model or catalog number

1116679

1116680

1116770

1116771

Companies
Manufacturer

ABBOTT DIAGNOSTIC TECHNOLOGIES AS

KJELSASVEIEN 161, P.O. BOX 6863 RODELOKKA

OSLO

504

NORWAY