GeneXpert Dx System - Xpert MRSA Assay (2017-11-28)

Starting date:

November 28, 2017

Posting date:

February 1, 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, Hospitals, Healthcare Professionals

Identification number:

RA-65858

• 
  Reason
• 
  Affected products

Affected products

GeneXpert Dx System - Xpert MRSA Assay

Reason

Some customers have experienced a higher number of invalid results than would typically be expected when using this test and its intended use specimen types.

Affected products