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IDS-iSYS Free Testosterone
IMMUNODIAGNOSTIC SYSTEMS LIMITED · Model IS-5300 · UDI-DI 05060169691230
CDZ
Prescription
1
510(k) clearances
163
Adverse events
19
Recalls
57
Facilities
Description
The IDS-iSYS Free Testosterone assay is an in vitro diagnostic device intended for the quantitative determination of free testosterone in human serum or plasma on the IDS System. Results are to be used as an aid in the diagnosis of androgen disorders
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-12 | Tosoh Bioscience Inc | The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-05-05 | Beckman Coulter, Inc. | Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 5 |
| 2024-12-03 | Qualigen Inc | Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 24 |
| 2024-07-05 | DRG International, Inc. | Invalid Controls. The Low Control is out of range; too high which causes invalid runs that would result in repeating the runs and delays for reporting results to patients. |
| 2022-10-25 | Siemens Healthcare Diagnostics, Inc. | Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Total Testosterone Assa |
| 2019-11-06 | Qualigen Inc | The chemiluminescent immunoassay has been noted to have higher than expected results which may result in inaccurate quantitative determinations of Sex Hormone Binding Globulin in h |
| 2019-05-21 | DRG Instruments GmbH | Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) w |
| 2018-11-30 | Tosoh Bioscience Inc | |
| 2018-03-21 | Siemens Healthcare Diagnostics, Inc. | The diluent may have an incomplete slit on the septum in the cap of the vial. A diluent cap with a defective septum has the potential to cause erroneously elevated results if a sa |
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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.