MATCH IT! DNA Software (2018-02-11)

Starting date:

February 11, 2018

Posting date:

March 19, 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-66180

• 
  Reason
• 
  Affected products

Affected products

MATCH IT! DNA Software

Reason

It has been determined that when using MATCH IT! DNA Software v1.2.3 (with the pairwise functionality turned off) on a window 7, 32-bit computer to analyze HLA-A typing, the software does not correctly load the suggested assignment table when navigating between samples that contain complex numbers of HLA-A allele-string pairs. When the user navigates from one sample to the next, the software does not automatically assign a typing into the assigned view field when the auto assign feature is activated in preferences. If the user attempts to make a manual assignment to the assigned view field, the software will crash.

It has also been determined that there is a possibility of a mistype when using MATCH IT! DNA Software v1.2.4 (with the pairwise functionality turned off) on a window 7, 32-bit computer to analyze HLA-A typing. If the user navigates from one sample to the next sample, the software can maintain the previous sample typing in the assigned view field in addition to the suggested assignments. If the user attempts to make a manual assignment, the software will freeze. There is no warning that the typing in assigned view is incorrect.

Affected products