RAPIDPoint 500 System (2018-10-02)

Starting date:

October 2, 2019

Posting date:

November 29, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71728

Last updated: 2019-12-02

• Reason
• Affected products

Affected Products

RAPIDPoint 500 System

Reason

Siemens has identified an issue with the optional custom demographics software feature on RAPIDPoint 500 analyzers with software versions V2.2, V2.3 or V2.3.1. This optional feature enables you to define up to 10 free text fields. The issue impacts the custom demographics fields sent to the lis and viewed/printed from the data recall screen. These fields may get mixed up with custom demographics from another patient. The sample printout obtained at the time the sample was run is not impacted.

Affected products