Health product recall

Alinity HQ Analyzer

Last updated

Summary

Product
Alinity HQ Analyzer
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Alinity HQ Analyzer

More than 10 numbers, contact manufacturer.

09P68-01

Issue

Abbott has identified the following issues when using Alinity HQ Analyzer software version 5.6 and below which will be corrected in software version 5.9.

Issue 1: When processing a CBC+diff sample that immediately follows a CBC+diff+retic sample, diluent may backflow into the RBC dilution cup. This may result in falsely low red blood cell (RBC) results and consequently falsely high mean cell hemoglobin concentration (MCHC), falsely high mean cell hemoglobin (MCH), and falsely low hematocrit (HCT).

Issue 2: An overestimation of the basophil (baso) count may occur on some samples when cell events are incorrectly counted as baso during sample analysis. this may result in falsely increased baso counts and %b (%baso).

Recall start date: June 21, 2024

 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies

Abbott Laboratories

4551 Great America Pkwy, Santa Clara, California, United States, 95054

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75791

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