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Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA product code MTF · Class 3 · Unknown

37
Registered devices
518
Adverse events
9
Recalls
0
510(k) clearances

Devices with this code

Alinity — Abbott Ireland DiagnosticsAlinity — Abbott Ireland DiagnosticsAccess Hybritech PSA Sample Diluent — Beckman Coulter, Inc.VIDAS® — BIOMERIEUX SAAtellica IM Calibrator Q — Siemens Healthcare Diagnostics Inc.Elecsys total PSA — Roche Diagnostics GmbHDimension® clinical chemistry system TPSA Flex® reagent cartridge — Siemens Healthcare Diagnostics Inc.IMMULITE®/IMMULITE®1000 Systems PTS PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDDimension Vista® System TPSA Flex® Reagent Cartridge — Siemens Healthcare Diagnostics Inc.IMMULITE® 2000 Systems PTS PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDElecsys tPSA — Roche Diagnostics GmbHAlinity — Abbott Ireland Diagnosticstotal PSA Calset II — Roche Diagnostics GmbHElecsys Total PSA Immunoassay — Roche Diagnostics GmbHARCHITECT — Abbott Ireland Diagnosticstotal PSA CalSet II — Roche Diagnostics GmbHADVIA Centaur® Systems, ACS:180® Systems Calibrator Q — Siemens Healthcare Diagnostics Inc.Atellica IM Calibrator Q — Siemens Healthcare Diagnostics Inc.Elecsys Total PSA Immunoassay — Roche Diagnostics GmbHAlinity — Abbott Ireland DiagnosticsIMMULITE®/IMMULITE®1000 Systems 3PS Third Generation PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDElecsys total PSA — Roche Diagnostics GmbHIMMULITE®Systems sPS CONTROL Third Generation PSA — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDElecsys Total PSA CalSet II — Roche Diagnostics GmbH

Recent recalls

DateFirmReason
2024-09-30Siemens Healthcare Diagnostics, Inc.The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructi
2016-12-21Siemens Healthcare Diagnostics, Inc.Negative bias results with the IMMULITE /IMMULITE 1000 Third Generation PSA (prostate-specific antigen) kit was confirmed for two lots (D0119 and D0120). The i
2016-12-21Siemens Healthcare Diagnostics, Inc.Negative bias with IMMULITE /IMMULITE 1000 Third Generation PSA (prostate-specific antigen) kit. The investigation by Siemens has confirmed that patient sample
2016-11-18Siemens Healthcare Diagnostics, Inc.Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect expecta
2016-11-18Siemens Healthcare Diagnostics, Inc.Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect expectation i
2015-12-29Siemens Healthcare Diagnostics, IncPSA assay is not meeting the High Dose Hook Effect expectation in the Instructions for Use (IFU).
2013-10-14BioMerieux SAProduct is not approved or authorized for distribution in the US.
2012-04-02Siemens Healthcare Diagnostics, Inc.Siemens has confirmed a report of leaking Flex(R) reagent cartridge lot 11300BB from Dimension Vista(R) TPSA; when a leaking Flex(R) is used, patient test resul
2008-03-24Siemens Healthcare Diagnostics Inc.False Results: The product may exhibit falsely elevated results. The affected lots demonstrate sporadic variability in recovery of calibrator and quality cont

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.