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:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Health products - Medical devices - 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