Public recall detail

Alinity HQ Analyzer

2024-07-05

medium
Recall Safety notice
Quick summary

Quick summary: Alinity HQ Analyzer. Date: 2024-07-05.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Alinity HQ Analyzer. Date: 2024-07-05.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAbbott Laboratories
ProductAlinity HQ Analyzer
IssueMedical devices - Performance
Recall classType II
IdentificationRA-75791

Affected products

ProductAlinity HQ Analyzer
LotMore than 10 numbers, contact manufacturer.
Model09P68-01
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAlinity HQ Analyzer

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Haematology
CompaniesAbbott Laboratories 4551 Great America Pkwy, Santa Clara, California, United States, 95054
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-75791
Background{}
CompaniesAbbott Laboratories 4551 Great America Pkwy, Santa Clara, California, United States, 95054
AudiencesHealthcare
Source updated2024-07-05

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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