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ADVIA CENTAUR SYSTEM AND CP SYSTEM (2016-07-29)
- Starting date:
- July 29, 2016
- Posting date:
- August 10, 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-59754
Affected products
- A. ADVIA CENTAUR CP SYSTEM - PSA ASSAY
- B. ADVIA CENTAUR SYSTEM - PSA ASSAY
Reason
Siemens is issuing a field safety notice to customers to emphasize that the prostate-specific antigen (PSA) values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy. Siemens is providing a limit of quantitation (loq) for the ADVIA Centaur PSA assay at this time. The loq for PSA on the ADVIA Centaur CP will follow
Affected products
A. ADVIA CENTAUR CP SYSTEM - PSA ASSAY
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 02676506
- 06574155
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES
B. ADVIA CENTAUR SYSTEM - PSA ASSAY
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
02676506
06574155
Companies
- Manufacturer
-
Siemens Healthcare Diagnostics Inc.
511 Benedict Ave
Tarrytown
10591
New York
UNITED STATES