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Advia Centaur Systems
- 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, Non-medicinal Ingredient
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-15570
Recalled Products
A. Advia Centaur System – Instrument
B. Advia Centaur XP System – Instrument
C. Advia Centaur XP System – Instrument
D. Advia Centaur XP System – Instrument
E. Advia Centaur System – Instrument
F. 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
A. Advia Centaur System - Instrument
Lot or serial number
Not Applicable
Model or catalog number
04911855, 078-A001-14
Companies
- Manufacturer
- Siemens Heathcare Diagnostics Inc.
B. Advia Centaur XP System - Instrument
Lot or serial number
Not Applicable
Model or catalog number
078-A010-07, 09066916
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES
C. Advia Centaur XP System - Instrument
Lot or serial number
Not Applicable
Model or catalog number
078-A010-07, 09066916
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES
D. Advia Centaur XP System - Instrument
Lot or serial number
Not Applicable
Model or catalog number
078-A010-07, 09066916
E. Advia Centaur System - Instrument
Lot or serial number
Not Applicable
Model or catalog number
04911855, 078-A001-14
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
500 GBC Drive, Mailstop 514, PO Box 6101
Newark
19714-6101
Delaware
UNITED STATES
F. Advia Centaur System - Instrument
Lot or serial number
Not Applicable
Model or catalog number
04911855, 078-A001-14
Companies
- Manufacturer
- Siemens Heathcare Diagnostics Inc.