Advia Centaur and Centaur XP System Instruments (2014-08-20)

Starting date:

August 20, 2014

Posting date:

September 24, 2014

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-41489

• Reason
• Affected products

Recalled products

1. Advia Centaur System - Instrument Class 3
2. Advia Centaur XP System - Instrument Class 2
3. Advia Centaur XP System - Instrument Class IV
4. Advia Centaur XP System - Instrument Class III
5. Advia Centaur System - Instrument Class II
6. Advia Centaur System - Instrument Class IV

Reason

Manufacturer advises that a specific scenario has been identified that causes patient demographics data (patient name, age, sex) from the previous order received from the Laboratory Information System (LIS) to be merged with the next order. The incorrect patient demographics data will display on the Advia Centaur/Advia Centaur XP user interface, print on instrument-generated reports, and will be transmitted to the LIS with the test result.

Affected products