Health product recall

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

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

A. ALINITY HQ ANALYZER

Lot or serial number

All serial numbers.

Model or catalog number

09P68-01

Companies
Manufacturer

Abbott GmbH & Co. KG

Max-Planck-Ring 2

Wiesbaden

65205

GERMANY


B. ALINITY HS SLIDE MAKER STAINER MODULE

Lot or serial number

All serial numbers.

Model or catalog number

09P69-01

Companies
Manufacturer

Abbott GmbH & Co. KG

Max-Planck-Ring 2

Wiesbaden

65205

GERMANY