Advia Centaur System – Instruments (Monthly and Daily Cleaning Procedure)

Starting date:

August 16, 2012

Posting date:

September 3, 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, Healthcare Professionals, Hospitals

Identification number:

RA-23851

• Reason
• Affected products

Recalled products

1. Advia Centaur System – Instrument
2. Advia Centaur XP System – Instrument
3. Advia Centaur XP System – Instrument
4. Advia Centaur XP System – Instrument
5. Advia Centaur System – Instrument
6. Advia Centaur System – Instrument

Reason

The Monthly Cleaning Procedure (MCP) maintenance, under certain circumstances, may result in residual cleaning solution (Bleach) in the Reagent Probe 1 (RP1) fluidics and the water reservoir causing false results. Tests affected are Total Human Chorionic Gonadotropin (THCG), Progesterone and Prostate Specific Antigen (PSA). The Daily Cleaning Procedure (DCP) under certain circumstances may result in residual cleaning solution (Bleach) in the water line causing false results that use water for test processing. Test affected is Toxoplasma M (Toxo M).

Affected products