Health product recall

Alinity hq Analyzer (2019-12-20)

Starting date:
December 20, 2019
Posting date:
January 20, 2020
Type of communication:
Medical Device Recall
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Medical Devices
General Public, Healthcare Professionals, Hospitals
Identification number:

Last updated: 2020-01-21

Affected Products

Alinity hq Analyzer


  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
  2. samples.

  3. 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

Alinity hq Analyzer

Lot or serial number
  • HQ00293
  • HQ00410
  • HQ00411
  • HQ00432
Model or catalog number



Abbott GmbH and Co. K.G.

Max Planck Ring 2