Advia Centaur System - Instruments

Starting date:

November 8, 2012

Posting date:

December 10, 2012

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public (GP), Healthcare Professionals, Hospitals

Identification number:

RA-16321

• 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

The wash interconnect circuit board on the Advia Centaur / Advia Centaur XP can fail due to contamination on the board during manufacturing and/or during use.  When a failure occurs, it is possible to have incorrect reporting of the wash1 sensors status. The fluid line of either sensor (S1 or S2) is reported to be empty when it is actually full, or reported to be full when it is empty.  These failures could either lead to the system not detecting an empty wash1 bottle or reservoir, or stop the system from running due to a supposedly empty wash1 reservoir.  If the sensors both fail in the "wet" state due to the board malfunction, an erroneous but believable result may be released to the physician which is falsely high or low (depending on the assay architecture - Competitive or Sandwich).

Affected products