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Health Canada Medical devices

Alinity Hs/Hq System

Issued May 16, 2022
Issue
The purpose of this notification is to inform you of a product recall for Alinty Hq analyzer and Alinity Hs slide maker stainer module. Abbott hematology identified that product information letter (pi-l) 1035-2020 issued for fa18jun2020, which contained open Alinity h-series issues from previous field actions (fa11oct2018-revision 01, fa11sep2019, fa04oct2019), stopped distribution to new customer installations in September 2020 when software version 4.3 was released. Recall start date: May 10, 2022
Hazard description
Performance
Product
Product name
Alinity Hs/Hq System
Reference
ID
RA-64175