TDWorkstation (2018-02-03)

Starting date:

February 3, 2018

Posting date:

April 3, 2018

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-66246

• 
  Reason
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  Affected products

Affected products

TDWORKSTATION

Reason

Software anomaly (reference dr35041) with TD-Synergy version v11.31 or later. This anomaly results in consequences for users only when the TD-Synergy system is connected to another system and uses one of these two communication methods. Transmission of results in HL7 format from TD-Synergy to a host system including results of date type. Sharing of TD-Synergy data with a reference laboratory including complementary parameters of date type.

This anomaly affects only results of date type or complementary parameters of date type.

Nature of the defect (real or potential):

• Depending on the date format used, the system may invert the date’s day and month. For example, the system can transmit a date as “February 3, 2015” instead of “March 2, 2015”
• The system transmits results of date type or review requests with complementary parameters of date type in HL7 format.

The communication module’s service window uses a local account system that has a regional parameter corresponding to common wording that uses a date format in which the day precedes the month (e.g., “day/month/year” format such as “dd/mm/yy” or “d/m/yy”).

Or

The communication module’s service window uses a specific user account, and this user uses a date format in which the day precedes the month (e.g., “day/month/year” format such as “dd/mm/yy” or “d/m/yy”).

The defect does not occur if the date format used is “month/day/year” (mm/dd/yyyy).

Affected products