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Triiodothyronine (T3) ELISA

DRG International Inc · Model EIA-1780 · UDI-DI 00840239017802

CDP Prescription

510(k) clearances

1,979

Adverse events

Recalls

Facilities

Description

This Triiodothyronine (T3) ELISA is intended for the quantitative determination of triiodothyronine (T3) concentration in human serum. This test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

Recalls

Date	Firm	Reason
2024-04-09	QUIDELORTHO	T3 Reagent Packs used with Free T3 Calibrators may produce positively biased results for patient and quality control samples. The positive bias may cause erroneous patient results
2023-03-15	Beckman Coulter, Inc.	The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers nor Free T3 results g
2019-04-30	Beckman Coulter Inc.	The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422
2019-04-30	Beckman Coulter Inc.	The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422
2018-11-30	Tosoh Bioscience Inc
2018-10-12	Abbott Ireland Diagnostics Division	Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a reagent carryover when testing on board with specific assays on the ARCHITEC
2018-10-12	Abbott Ireland Diagnostics Division	Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a reagent carryover when testing on board with specific assays on the ARCHITEC
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.
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.
2017-07-28	Siemens Healthcare Diagnostics, Inc	Siemens has identified an issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems T3 kit lots ending in 198 on the ADVIA Centaur XPT system.

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Data 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.