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 All lots. 08N53-002

Issue

Abbott has identified three potential issues which may have impacted the amplification detection unit(s) (ADU) installed on your Alinity M system.
1.    systems which had their ADU's serviced may have an incorrect boardvalue (calibration data file) referenced causing a misconfiguration of the calibration. 
2.    inability of maintenance and diagnostics 2300 (amp detect optical calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 
3.    under specific conditions during the adu manufacturing process, an incorrect calibration may potentially have been configured.

Recall start date: December 13, 2022
 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - 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-72407