Remisol Advance (2020-04-22)

Starting date:

April 22, 2020

Posting date:

May 8, 2020

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-73041

Last updated: 2020-05-08

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  Reason
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  Affected products

Affected Products

1. Remisol Advance

Reason

Results from repeated run for the hematology test panels WBC, UWBC and PLT are deleted in radv if certain options are set or the rerun was not ordered by Remisol Advance directly but manually on DXH 600 / 800 / 900 / 690t. In a worst case, re-run results may not be generated if ordered from the DXH analyzer and the original results would be reported, which may be erroneous.

Affected products