DXH 500 (2016-07-19)

Starting date:

July 19, 2016

Posting date:

July 29, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-59628

• Reason
• Affected products

Affected products

A. DXH 500

Reason

A specimen misidentification may occur, despite an active software prompt on the screen, when the following sequence of events occurs:

• pending test orders exist on the worklist
• a new specimen ID is added using the "next" icon on the sample analysis - patient results screen or by scanning a specimen barcode label
• the user leaves the screen before aspirating the new specimen
• upon returning to the sample analysis - patient results screen, the following prompt displays "worklist contains entries. Confirm next specimen ID is correct before processing specimen"
• the next specimen ID field of the DxH 500 defaults to the first specimen ID on the worklist  which may not be the newest specimen identified
• the issue occurs when the user fails to verify the specimen ID

The issue does not occur when the worklist has no pending test orders.

Affected products