Health product recall

Alinity Hs/Hq System

Last updated

Summary

Product
Alinity Hs/Hq System
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare
Industry

Affected products

Affected products

Lot or serial number

Model or catalog number

Alinity Hs Slide Maker Stainer Module

HS00191
HS00241
HS00240
HS00256
HS00242

09P69-01

Alinity Hq Analyzer

HQ00903
HQ00900
HQ00893
HQ00410
HQ00411
HQ00787
HQ00905
HQ00899
HQ00432
HQ00906
HQ00792
HQ00901

09P68-01

Issue

The Alinity h-series system control center (SCC) application software version 4.3 (and below) and the local user interface (LUI) embedded analyzer engine (EAE) contain a cybersecurity certificate that expired on 08sep2022.  Whenever the software checks for the cybersecurity certificate expiration date and it detects that it has expired, the SCC and/or LUI becomes nonfunctional. This renders the Alinity h-series unable to process samples. There is no impact to cybersecurity or results integrity on the Alinity h-series with this issue.

Recall start date: September 12, 2022

Additional information

Details
Original published date: 2022-09-26
Alert / recall type
Health product recall
Category
Health product - Medical device - Haematology
Health product - Medical device - Pathology
Companies

Abbott Laboratories

4551 Great America Pkwy, Santa Clara, California, United States, 95054

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-64565