Prostate-specific Antigen (psa) For Management Of Prostate Cancers

PSA Test

Distribution without premarket approval/clearance.

FastPack Total PSA Immunoassay

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

PSA ELISA Kit.

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

Free PSA ELISA Kit.

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

Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205.

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.

FastPack(R) Total PSA Immunoassay; Catalog #: 25000001

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

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).

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.

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.

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