Siemens ADVIA Centaur PSA Assay Recalled for High Dose Hook Effect Failure
Siemens Healthcare Diagnostics is recalling ADVIA Centaur PSA Assay kits because they do not meet the High Dose Hook Effect expectation in the Instructions for Use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a performance deviation (High Dose Hook Effect) rather than a direct physical injury or high-risk pathogen, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 55,754 kits of the ADVIA Centaur PSA Assay. The affected products include 100-test kits (Catalog Number 06574155/SMN 10310292) and 500-test kits (Catalog Number 02676506/SMN 10310293). These in vitro diagnostic assays are intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the ADVIA Centaur/XP/XPT/CP Systems.
The recall was initiated because the PSA assay is not meeting the High Dose Hook Effect expectation specified in the Instructions for Use (IFU). This performance deviation may affect the accuracy of test results for patients with high PSA levels.
The affected kits were distributed worldwide, including US Nationwide (including Puerto Rico) and numerous countries across Europe, Asia, the Americas, and the Middle East. Specific lot numbers and UDI codes are listed in the agency's recall record. Users of these kits should contact Siemens Healthcare Diagnostics for further instructions on how to proceed.
The recalled product
- Product
- ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 55,754
Distribution
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