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ADVIA CENTAUR SYSTEMS (2015-12-30)
- Starting date:
- December 30, 2015
- Posting date:
- January 22, 2016
- 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-56778
Affected Products
- ADVIA CENTAUR CP SYSTEM - PROSTATE-SPECIFIC ANTIGEN
- ADVIA CENTAUR SYSTEM - PROSTATE-SPECIFIC ANTIGEN
Reason
Not meeting the current High-Dose Hook Effect expectation in the Instructions For Use (IFU). The ADVIA Centaur systems PSA assay range is 0.01-100 ng/mL (μg/L). The ADVIA Centaur Systems PSA IFU states that patient samples with high total PSA levels can cause a paradoxical decrease in the Relative Light Units (RLUs) (high-dose hook effect). In this assay, patient samples with total PSA levels as high as 10,000 ng/mL (μg /L) will assay greater than 100 ng/mL (μg/L).
Affected products
A. ADVIA CENTAUR CP SYSTEM - PROSTATE-SPECIFIC ANTIGEN
Lot or serial number
ending in 263 and above
Model or catalog number
118156
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
B. ADVIA CENTAUR SYSTEM - PROSTATE-SPECIFIC ANTIGEN
Lot or serial number
ending in 263 and above
Model or catalog number
118157
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES