ELECSYS FT4 III ASSAY Adverse Event — Malfunction (MDR 1823260-2020-90080)
ELECSYS FT4 III ASSAY Adverse Event — Malfunction (MDR 1823260-2020-90080) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ELECSYS FT4 III ASSAY; Generic name: RADIOIMMUNOASSAY, FREE THYROXINE; Manufacturer: HITACHI HIGH TECH CORP..
| Device | ELECSYS FT4 III ASSAY |
|---|---|
| Generic name | RADIOIMMUNOASSAY, FREE THYROXINE |
| Manufacturer | HITACHI HIGH TECH CORP. |
| Report number | 1823260-2020-90080 |
| Event type | Malfunction |
| Product problem | N |
| Date received | 2020-04-28 |
| Narrative | FOR ALL SEVEN EVENTS, THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. DIFFERENT ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS IS RELATED TO THE DIFFERENCES OF THE SETUPS OF THE ASSAYS, THE ANTIBODIES USED, AND DIFFERENCES OF THE STANDARDIZATION MATERIALS AND PROCEDURES USED. THERE WERE NO FOLLOW UP ACTIONS FOR FIVE OF THESE EVENTS. FOLLOW UP ACTIONS FOR ONE OF THESE EVE |
| Source | openFDA MAUDE (device adverse events) |
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