Health product recall

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

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

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

Lot or serial number

3004895
3005391
3005538

Model or catalog number

303285
888622
PLX

Companies
Manufacturer

Immucor GTI Diagnostics, Inc.,

20925 Crossroads Circle,

Waukesha

53186

UNITED STATES