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Alinity hs hq system

Official notice

16 May 2022

Last checked

16 May 2022

Medium riskHealth Canada

An official Health Canada notice concerns Alinity hs hq system. 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 Published 2022-05-16.

What to do now

Contact the manufacturer if you require additional information.

Recall number

64175

Official notice

2022-05-16

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

64175

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Affected products

Product 1

Affected products - Alinity Hs Slide Maker Stainer Module, Lot or Serial Number - HS00256 HS00241 HS00242 HS00240, Model or catalogue number - 09P69-01

Product 2

Affected products - Alinity Hq Analyzer, Lot or Serial Number - HQ00906 HQ00899 HQ00792 HQ00905 HQ00900 HQ00903 HQ00901 HQ00787, Model or catalogue number - 09P68-01

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Abbott Laboratories, Alinity Hs Hq System.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

64175

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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