Rapidpoint and Rapidlab Systems (2013-09-24)

Starting date:

September 24, 2013

Posting date:

October 31, 2013

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-36479

• Reason
• Affected products

Recalled Products

A. Rapidpoint 400 System
B. Rapidpoint 405 System - Analyzer
C. Rapidlab 1260 System - Analyzer
D. Rapidlab 1240 System - Analyzer
E. Rapidlab 1265 System - Analyzer
F. Rapidlab 1245 System - Analyzer
G. Rapidpoint 500 System - Main Unit

Reason

Users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample. A patient sample mismatch could be caused by:

1. Inadvertently accepting the pre-selected patient IDon the demographics screen 
2. Overwriting sample demographics by incorrect operation of the patient list button 
3. Scanning the wrong barcode ID
4. Manually typing in the wrong ID

In each of these cases, failure to check the correct demographics screen before moving on to the results screen will assign the wrong demographics to the sample being tested.

Affected products