Phadia 250 Instrument (including software) (2017-11-29)

Starting date:

November 29, 2017

Posting date:

January 29, 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, Healthcare Professionals, Hospitals

Identification number:

RA-65810

• 
  Reason
• 
  Affected products

Affected products

Phadia 250 Instrument (including software)

Reason

Erroneous results may occur as a result of a software issue when specific conditions occur with the Phadia 250. The issue can occur with all versions of the Phadia Prime Software up to and including version 2.1.4. The issue will cause software to disregard default dilution factors for rejected samples, when using the "ok to all" function for retesting of samples if specific criteria are met.

Affected products