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FREND PSA Plus
NanoEnTek, Inc. · Model FRPS 025 · UDI-DI 08809317540481
LTJ
Prescription
10
510(k) clearances
653
Adverse events (1 deaths)
12
Recalls
31
Facilities
Description
It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specimen using FREND System.
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.