Siemens ADVIA Centaur PSA Assay Recall for Clinical Interpretation Clarification
Siemens Healthcare Diagnostics is recalling ADVIA Centaur PSA Assay kits to emphasize that PSA values must be interpreted according to current clinical guidelines for biochemical recurrence.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary measure to clarify clinical interpretation guidelines, fitting the 'Moderate' criteria for low-risk issues without reported injuries.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur PSA Assay kits (Catalog No. 06574155/SMN 10310292 and 02676506/SMN 10310293). The recall involves 100-test and 500-test kits distributed nationwide and in numerous international locations.
The recall was initiated to emphasize that Prostate-Specific Antigen (PSA) values obtained from these assays should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical prostatectomy. This is a communication-based recall intended to ensure proper clinical interpretation of the test results.
Healthcare facilities and laboratories that have received these specific lots of the ADVIA Centaur PSA Assay should review the communication and ensure that PSA values are interpreted according to the specified clinical guidelines. No specific adverse events or injuries are reported in the source text.
The recalled product
- Product
- ADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
Distribution
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