DXH 500 OPEN-VIAL HEMATOLOGY SYSTEM (2017-11-06)

Starting date:

November 6, 2017

Posting date:

November 24, 2017

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-65168

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  Reason
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  Affected products

Affected products

DXH 500 OPEN-VIAL HEMATOLOGY SYSTEM

Reason

Beckman Coulter has determined that if the bleach cycle is interrupted or aborted, the DxH 500 does not provide any warning message to the operator and the system does not sufficiently flush out residual bleach prior to sample analysis. Should a bleach cycle get interrupted, the subsequent software recovery to perform a diluter reset may not be sufficient to prevent the first immediate sample run from being affected. Patient results may be impacted due to residual bleach in the diluter when a sample is processed immediately after a bleach cycle is interrupted.

Affected products