Home › DRG International Inc › Total Thyroxine (T4) ELISA
Total Thyroxine (T4) ELISA
DRG International Inc · Model EIA-1781 · UDI-DI 00840239017819
10
510(k) clearances
24
Adverse events
12
Recalls
45
Facilities
Description
For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.
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.