Alinity hq Analyzer & Alinity hs slide maker stainer module (2019-09-16)

Starting date:

September 16, 2019

Posting date:

October 3, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71141

Last updated: 2019-10-03

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  Reason
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  Affected products

Affected Products

1. Alinity hq Analyzer
2. Alinity hs slide maker stainer module

Reason

Multiple issues have been identified for the Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module (outlined in customer letter). Abbott is releasing a software update, software version 4.0, and associated hardware changes, and an updated operations manual (80000023-107). This release addresses issues identified for the alinity hq and alinity hs software version 3.0 and below, alinity h-Series operations manual (80000023-106, 2018-10-08), and select hardware.

Affected products