Health product recall

Alinity M System

Last updated

Summary

Product
Alinity M System
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Alinity M System

S/N: 424

08N53-002

Issue

An issue has been identified regarding the led_ref_diff values on the amplification detection modules (adu). There is potential that there are incorrect led_ref_diff values installed on some Alinity M systems.

Recall start date: June 7, 2022

Additional information

Details
Original published date: 2022-06-16
Alert / recall type
Health product recall
Category
Health product - Medical device - Chemistry
Companies

Abbott Molecular Inc.

1300 E. Touhy Ave., Des Plaines, Illinois, United States, 60018

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-64260