ORTHO VISION Analyzer & ORTHO VISION Max Analyzer (2019-10-02)

Starting date:

October 2, 2019

Posting date:

October 25, 2019

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-71361

Last updated: 2019-10-25

• 
  Reason
• 
  Affected products

Affected Products

1. ORTHO VISION Analyzer
2. ORTHO VISION Max Analyzer

Reason

When two or more samples are loaded for processing with the same Sample ID (duplicate Sample IDs), the analyzer will display Apsw81 error messages ('Sample ID Is Not Unique') and one of the samples may be unexpectedly processed. The error message displayed with the Apsw81 error code states:

• 'The sample barcode ID is not unique ({Sample Barcode*}). The affected sample will not be processed.'
• *The actual duplicate ID is displayed in brackets.
• The unexpected processing creates the potential for results to be associated with the incorrect patient.

Affected products