Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-12-01Open, ClassifiedNo Marketing Application

  PSA Test

  Distribution without premarket approval/clearance.

• 2013-12-19TerminatedProcess change control

  FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA Immunoassay is designed for use with the FastPack System.

  Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

• 2011-03-11TerminatedPMA

  PSA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

  Product labels indicate that the products are for IVD use and they do not have an approved 510(k).

• 2011-03-11TerminatedPMA

  Free PSA ELISA Kit. BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.

  Product labels indicate that the products are for IVD use and they do not have an approved 510(k).

• 2009-04-28TerminatedPackaging process control

  Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205. The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems.

  Beckman Coulter incorrectly shipped Access Hybritech PSA calibrators containing dual calibration cards (Hybritech and WHO) to some Access Hybritech PSA Customers. The WHO calibration for PSA is not currently approved in the United States.

• 2008-12-22TerminatedOther

  FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 Is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack(R) Total PSA immunoassay is designed for use with the FastPack (R) System.

  The recall was initiated after the firm investigation of customer complaints of falsely elevated results determined the product was not meeting product performance expectations.

• 2008-09-16TerminatedOther

  COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid in monitoring patients for disease progress or response to therapy.

  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 methods, including the IMMULITE PSA kits. Coat-A-Count PSA IRMA results are, for example, approximately 20% lower when compared to results obtained with the IMMULITE 2000 Third Generation PSA assay (L2KUP).

• 2006-01-11TerminatedOther

  Roche Elecsys total PSA, catalog number 11731262322.

  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 analyzer.

• 2006-01-11TerminatedOther

  Roche Elecsys total PSA CalSet, catalog number 11731696322.

  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 analyzer.

• 2003-05-29TerminatedOther

  Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton.

  test results may be inaccurate by 0.2 to 0.5 ng/mL