OMNILAB V.12.0 - Laboratory Information System (Cytology-Pathology) (2019-01-15)

Starting date:

January 15, 2019

Posting date:

March 22, 2019

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-69368

• Reason
• Affected products

Affected Products

OMNILAB V.12.0 - Laboratory Information System (Cytology-Pathology)

Reason

In the Cytology-Pathology module, from the Barcode Reprinting screen which is available in the upper section of the main screen, it is possible to reprint labels for orders, jars, slides and blocks. In order to be able to reprint a label for one of the available types, the user needs to first enter an order number in the Accn # field, in the main screen. There was a unique unintended situation that caused a label to print with the wrong information.

After entering the order number in the main screen, a user clicked on the Reprint Barcode and selected the option Jar label. The user then unintentionally changed the order/specimen number displayed in the field that appears in the same screen to a different order number and then hit the Enter key. A label was printed out, but it included the wrong information. The patient's name matched the original order, while the order number and the specimen information matched the second order number to which it had been changed the Barcode Reprinting screen.

Affected products