Paklx - MATCH IT! Platelet Antibody Software (V1.1) (2017-09-29)

Starting date:

September 29, 2017

Posting date:

January 11, 2018

Type of communication:

Medical Device Recall

Subcategory:

Natural health products

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-65560

• 
  Reason
• 
  Affected products

Affected Products

Paklx - MATCH IT! Platelet Antibody Software (V1.1)

Reason

The Paklx Instructions For Use (IFU), version 303285.IFUEN REV K, and the MATCH IT! Platelet Antibody Software database were not aligned. The IFU states that a minimum of 60 events must be collected per bead region. The MATCH IT! Platelet Antibody Software database requires a minimum of 100 events per bead region. This discrepancy caused invalid results when using the MATCH IT! Platelet antibody software to analyze a bead.

Affected products