DSX- Revelation software 6.08-6.28 (2018-08-03)

Starting date:

August 3, 2018

Posting date:

September 17, 2018

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-67764

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  Reason
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  Affected products

Affected products

DSX- Revelation software 6.08-6.28

Reason

The DSX analyzer utilizes operating software Revelatlon. This software use set up as default with an algorithm for dealing with over/ under conversion. If an end user turns this off and they use the over limit in their Quality Control Equation the software will place 0.00 in the equation leading to an incorrect QC interpretation and potential incorrect value assigned to the result.

Affected products