Home › EUROIMMUN Medizinische Labordiagnostika AG › Free Triiodothyronine (FT3) ELISA
Free Triiodothyronine (FT3) ELISA
EUROIMMUN Medizinische Labordiagnostika AG · Model EQ 1016-9601 · UDI-DI 04049016139232
10
510(k) clearances
1,979
Adverse events
20
Recalls
50
Facilities
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.