Radioimmunoassay, Total Triiodothyronine
Ortho-clinical Diagnostics's record for this product code
MDR events6All time
Recalls2All time
510(k) clearances0All time
Recent MDR events
6 adverse event reports on file
- VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACKNov 21, 2019Malfunction3007111389-2019-00186
- VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL T3 REAGENT PACKNov 19, 2019Malfunction3007111389-2019-00183
- VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T3 REAGENT PACKSep 20, 2016Injury3007111389-2016-00174
- VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T3 REAGENT PACKSep 20, 2016Injury3007111389-2016-00176
- VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T3 REAGENT PACKSep 20, 2016Injury3007111389-2016-00175
- VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T3 REAGENT PACKSep 20, 2016Injury3007111389-2016-00177
Recalls
2 recall events for this product code
- TerminatedJun 4, 2015
The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.
View FDA record ↗ - TerminatedApr 20, 2006
Firm received complaints of biased results when using VITROS Signal Reagent, Lots 8350 and 8530. VITROS Signal Reagent is used with the VITROS Immunodiagnostic ECi/ECiQ laboratory system, and when used may produce inaccurate test results in some cases.
View FDA record ↗
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for Ortho-clinical Diagnostics under this product code.