Health product recall

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

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

DSX- Revelation software 6.08-6.28

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

65078-XXX

Companies
Manufacturer

Dynex Technologies Inc.

14340 Sullyfield Cir

Chantilly

20151-1621

Virginia

UNITED STATES