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ADVIA Centaur® PSA
Siemens Healthcare Diagnostics Inc. · Model 10310292 · UDI-DI 00630414203003
0
510(k) clearances
653
Adverse events (1 deaths)
12
Recalls
31
Facilities
Description
Prostate-specific Antigen (PSA) Assay Kit (1-pack) 100T
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. |
| 2016-08-09 | Siemens Healthcare Diagnostics, Inc | Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical recurrence following radical p |
| 2013-11-08 | Qualigen Inc | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2010-12-22 | BioCheck Inc | Product labels indicate that the products are for IVD use and they do not have an approved 510(k). |
| 2008-09-29 | Qualigen Inc | The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations. |
| 2008-05-21 | Siemens Medical Solutions Diagnostics | The field action was initiated after the firm confirmed that the Coat-A-Count PSA IRMA kit (IKPS1, 2, 5, X) exhibits a low bias, which is evident when comparing results with other |
| 2008-01-08 | Beckman Coulter Inc | Beckman Coulter incorrectly shipped Access Hybritech PSA calibrators containing dual calibration cards (Hybritech and WHO) to some Access Hybritech PSA Customers. The WHO calibrati |
| 2005-12-07 | Roche Diagnostics Corp. | There is the possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyz |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.