ALINITY HQ ANALYZER & ALINITY HS SLIDE MAKER STAINER MODULE (2019-10-10)

Starting date:

October 10, 2019

Posting date:

October 25, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71383

Last updated: 2019-10-25

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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

On 11 September 2019, Product Correction Letter FA11SEP2019 was provided to address issues identified in Software version 3.0 and below, Operations Manual (80000023-106, 2018-10-08) and select hardware.

Abbott Hematology has identified three issues with the release of Alinity h-series Analyzer Software Version 4.0. These will be corrected in future software and Operations Manual/ On-line Help update.

Canadian customers who have received shipments of the Alinity hq Analyzer and Alinity hs Slide Maker Stainer Module will be sent the Product Correction letter.

New customers will receive a product information letter with product (PI-P) for open/ unresolved/ unfixed issues.

Affected products