XN-10 and X-11 Modules (2017-04-04)

Starting date:

April 4, 2017

Posting date:

May 2, 2017

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-63136

• 
  Reason
• 
  Affected products

Affected Products

1. XN-10 Module
2. XN-11 Module

Reason

The protective plastic sheet that is intended to cover and protect electronic components inside the XN-series analyzers was not positioned correctly during manufacturing. Reagent from a leaking valve created a build-up of salt on an electronic component because of the misalignment of the protective sheet. The salt build-up created a salt bridge that allowed current to continue to flow, create heat, and eventually ignite adjacent resin parts inside the analyzer.

Affected products