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IDS SHBG
IMMUNODIAGNOSTIC SYSTEMS LIMITED · Model IS-5600 · UDI-DI 05060169691322
CDZ
Prescription
1
510(k) clearances
163
Adverse events
19
Recalls
57
Facilities
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.