Alinity hq Analyzer (2019-12-20)

Starting date:

December 20, 2019

Posting date:

January 20, 2020

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-72119

Last updated: 2020-01-21

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  Reason
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  Affected products

Affected Products

Alinity hq Analyzer

Reason

1. EAE memory leak - the embedded analyzer engine (EAE) logs on the Alinity hq instrument indicates the occurrence of a slow memory leak. Once the instrument has processed approximately 5000 samples, the system will start to display zeros (0.00) On the results screen along with algorithm failure data invalidating flags displayed on the extended tab of the results details screen on system control center (SCC) for certain

samples.


2. Pediatric tubes - when the pediatric sample tube BD microtainer map dipotassium EDTA 1.0mg is run in the closed mode, the Alinity-h software v 4.0 and above generates message code 3727 ""tube bottom not detected"" which indicates that the sample probe did not reach the tube bottom and sample was not aspirated. However, samples are aspirated, and results are invalidated by the system. This issue does not occur in open tube mode.

Affected products