Home › DRG Instruments Gesellschaft mit beschränkter Haftung › Free Thyroxine (fT4) ELISA
Free Thyroxine (fT4) ELISA
DRG Instruments Gesellschaft mit beschränkter Haftung · Model EIA-4109 · UDI-DI 04048474041095
KLI
Prescription
1
510(k) clearances
24
Adverse events
12
Recalls
45
Facilities
Description
The Quantitative Determination of Free Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-16 | Beckman Coulter, Inc. | Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A fal |
| 2024-02-08 | Beckman Coulter, Inc. | Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results. |
| 2021-10-18 | DRG International, Inc. | Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of pati |
| 2021-10-14 | BioCheck, Inc. | Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls. |
| 2020-03-10 | Ortho Clinical Diagnostics | The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations. |
| 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. |
| 2017-06-29 | Siemens Healthcare Diagnostics, Inc. | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely ele |
| 2016-06-02 | ORTHO-CLINICAL DIAGNOSTICS | Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack stor |
| 2014-02-20 | Ortho-Clinical Diagnostics | Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results. |
| 2011-03-10 | Beckman Coulter Inc. | The recall was initiated because the concentration of total T4 in samples from pregnant women is erroneously low (20%) when measured using the Access Total T4 assay. Erroneously lo |
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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.